{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2023-N-2177\" and posted_year = 2024 sorted by posted_date descending", "rows": [["FDA-2023-N-2177-7203", "FDA", "FDA-2023-N-2177", "Tab A - Final Rule-OMB Original Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:49:09Z", null, 0, 0, "09000064867fb99f"], ["FDA-2023-N-2177-7208", "FDA", "FDA-2023-N-2177", "Tab C - FRIA-OMB Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:49:30Z", null, 0, 0, "09000064867fb9a4"], ["FDA-2023-N-2177-7199", "FDA", "FDA-2023-N-2177", "Tab A - Proposed Rule-OMB Original Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:44:56Z", null, 0, 0, "09000064867fbbde"], ["FDA-2023-N-2177-7201", "FDA", "FDA-2023-N-2177", "Tab C - 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Final Rule-Comparison OMB Original to Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:49:13Z", null, 0, 0, "09000064867fb9a0"], ["FDA-2023-N-2177-7197", "FDA", "FDA-2023-N-2177", "Tab B - PRIA-Comparision OMB Original to Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:44:47Z", null, 0, 0, "09000064867fbbdc"], ["FDA-2023-N-2177-7195", "FDA", "FDA-2023-N-2177", "Memorandum - Medical Devices; Laboratory Developed Tests (proposed rule)", "Other", "Memorandum", "2024-11-04T05:00:00Z", 2024, 11, "2024-11-04T05:00:00Z", null, "2024-11-04T20:44:29Z", null, 0, 0, "09000064867fbc09"], ["FDA-2023-N-2177-7196", "FDA", "FDA-2023-N-2177", "Tab A - PRIA-OMB Original Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:44:43Z", null, 0, 0, "09000064867fbbdb"], ["FDA-2023-N-2177-7198", "FDA", "FDA-2023-N-2177", "Tab C - PRIA-OMB Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:44:51Z", null, 0, 0, "09000064867fbbdd"], ["FDA-2023-N-2177-7200", "FDA", "FDA-2023-N-2177", "Tab B - Proposed Rule-Comparison OMB Original to Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:45:00Z", null, 0, 0, "09000064867fbbdf"], ["FDA-2023-N-2177-7205", "FDA", "FDA-2023-N-2177", "Tab C - Final Rule-OMB Final Version", "Supporting & Related Material", "Background Material", "2024-11-04T05:00:00Z", 2024, 11, null, null, "2024-11-04T20:49:17Z", null, 0, 0, "09000064867fb9a1"], ["FDA-2023-N-2177-7192", "FDA", "FDA-2023-N-2177", "Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability", "Notice", "Notice of Availability", "2024-06-25T04:00:00Z", 2024, 6, "2024-06-25T04:00:00Z", null, "2024-06-25T12:21:21Z", "2024-13872", 0, 0, "09000064865c7228"], ["FDA-2023-N-2177-7193", "FDA", "FDA-2023-N-2177", "Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff", "Other", "Guidance", "2024-06-25T04:00:00Z", 2024, 6, "2024-06-25T04:00:00Z", null, "2025-06-27T09:00:17Z", null, 1, 0, "09000064865c704f"], ["FDA-2023-N-2177-7129", "FDA", "FDA-2023-N-2177", "FRIA Reference 13 - Hopewell, et al., \"No Impact of KIF6 Genotype on Vascular Risk and Statin Response Among 18,348 Randomized Patients in the Heart Protection Study,\" Journal of the American College of Cardiology", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T20:21:53Z", null, 0, 0, "090000648652ddcf"], ["FDA-2023-N-2177-7149", "FDA", "FDA-2023-N-2177", "FRIA Reference 33 - Newman-Toker, \"Rate of diagnostic errors and serious misdiagnosis-related harms for major vascular events, infections, and cancers: toward a national incidence estimate using the \u201cBig Three\u201d,\" Diagnosis", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T20:33:05Z", null, 0, 0, "090000648652e198"], ["FDA-2023-N-2177-7161", "FDA", "FDA-2023-N-2177", "FRIA Reference 45 - Raisi-Estabragh, et al., \"Differential Patterns and Outcomes of 20.6 Million Cardiovascular Emergency Department Encounters for Men and Women in the United States\"", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T20:45:20Z", null, 0, 0, "090000648652e2b3"], ["FDA-2023-N-2177-7165", "FDA", "FDA-2023-N-2177", "FRIA Reference 49 - Centers for Disease Control and Prevention, \"National Notifiable Diseases Surveillance System. 2019 annual tables of infectious disease data,\" 2021", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T22:00:19Z", null, 0, 0, "090000648652e2fe"], ["FDA-2023-N-2177-7182", "FDA", "FDA-2023-N-2177", "FRIA Reference 66 - Gerhard, Fisher, and Feldman, \"Genetic Testing for Inherited Cardiac Diseases in Underserved Populations of Non-European Ancestry: Double Disparity\"", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T22:05:51Z", null, 0, 0, "090000648652e410"], ["FDA-2023-N-2177-7162", "FDA", "FDA-2023-N-2177", "FRIA Reference 46 - Hickner, et al., \"Primary Care Physicians' Challenges in Ordering Clinical Laboratory Tests and Interpreting Results\"", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T21:59:08Z", null, 0, 0, "090000648652e2b4"], ["FDA-2023-N-2177-7015", "FDA", "FDA-2023-N-2177", "Reference 165 - FDA, \u201cPremarket Approval (PMA) Database\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:30:46Z", null, 0, 0, "0900006486529f84"], ["FDA-2023-N-2177-7017", "FDA", "FDA-2023-N-2177", "Reference 167 - FDA, \u201cEstablishment Registration & Device Listing Database\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:31:05Z", null, 0, 0, "090000648652a010"], ["FDA-2023-N-2177-7055", "FDA", "FDA-2023-N-2177", "Reference 205 - Comment to the Docket from American Society for Microbiology Re: Docket No. FDA-2023-N-2177 (December 4, 2023)", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:38:48Z", null, 0, 0, "090000648652d30c"], ["FDA-2023-N-2177-7078", "FDA", "FDA-2023-N-2177", "Reference 228 - \u201cSusceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive Web Page; Reopening of a Public Docket; Request for Comments,\u201d 83 FR 8883 (2018)", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:44:36Z", null, 0, 0, "090000648652d67c"], ["FDA-2023-N-2177-7047", "FDA", "FDA-2023-N-2177", "Reference 197 - FDA, 510(k) Substantial Equivalence Determination Decision Summary, Selux AST System; Model AST Gen 1.0, K211748, Decision Date April 19, 2023", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:37:19Z", null, 0, 0, "090000648652c8ba"], ["FDA-2023-N-2177-7065", "FDA", "FDA-2023-N-2177", "Reference 215 - Zhang, \u201cBionano Genomics Keeps Focus on Clinical Applications for Optical Genome Mapping\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:40:30Z", null, 0, 0, "090000648652d347"], ["FDA-2023-N-2177-7076", "FDA", "FDA-2023-N-2177", "Reference 226 - FDA, \u201cAntimicrobial Susceptibility Test (AST) System Devices \u2013 Updating Breakpoints in Device Labeling; Guidance for Industry and Food and Drug Administration Staff,\u201d September 29, 2023", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:44:19Z", null, 0, 0, "090000648652d389"], ["FDA-2023-N-2177-7016", "FDA", "FDA-2023-N-2177", "Reference 166 - FDA, \u201cDevice Classification Under Section 513(f)(2)(De Novo) Database\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:30:53Z", null, 0, 0, "090000648652a00d"], ["FDA-2023-N-2177-7025", "FDA", "FDA-2023-N-2177", "Reference 175 - FDA, \u201cDevice Registration and Listing\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:32:51Z", null, 0, 0, "090000648652a1b9"], ["FDA-2023-N-2177-7040", "FDA", "FDA-2023-N-2177", "Reference 190 - FDA, \u201cContent of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff,\u201d June 14, 2023", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:36:08Z", null, 0, 0, "090000648652a4d0"], ["FDA-2023-N-2177-7100", "FDA", "FDA-2023-N-2177", "Reference 250 - FDA, \u201cStatistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Guidance for Industry and FDA Staff,\u201d March 13, 2007", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:48:21Z", null, 0, 0, "090000648652d7f1"], ["FDA-2023-N-2177-7114", "FDA", "FDA-2023-N-2177", "Reference 264 - FDA, \u201cOncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:52:05Z", null, 0, 0, "090000648652d8b0"], ["FDA-2023-N-2177-6906", "FDA", "FDA-2023-N-2177", "Reference 56 - FDA, \u201c510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:09:57Z", null, 0, 0, "0900006486523e25"], ["FDA-2023-N-2177-6911", "FDA", "FDA-2023-N-2177", "Reference 61 - FDA, \u201cDeciding When to Submit a 510(k) for a Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:10:48Z", null, 0, 0, "0900006486528f79"], ["FDA-2023-N-2177-7030", "FDA", "FDA-2023-N-2177", "Reference 180 - FDA, \u201cLabeling: Regulatory Requirements for Medical Devices,\u201d August, 1989", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:34:23Z", null, 0, 0, "090000648652a20b"], ["FDA-2023-N-2177-7067", "FDA", "FDA-2023-N-2177", "Reference 217 - Martin, et al., \u201cClinical Use of Current Polygenic Risk Scores May Exacerbate Health Disparities\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:40:45Z", null, 0, 0, "090000648652d34e"], ["FDA-2023-N-2177-7044", "FDA", "FDA-2023-N-2177", "Reference 194 - FDA, De Novo Decision Summary, The 23andME Personal Genome Service (PGS) Pharmacogenetic Reports, DEN180028, Decision date October 31, 2018", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:36:37Z", null, 0, 0, "090000648652a4d5"], ["FDA-2023-N-2177-7061", "FDA", "FDA-2023-N-2177", "Reference 211 - FDA, \u201cDeciding When to Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff,\u201d October 25, 2017", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:39:59Z", null, 0, 0, "090000648652d331"], ["FDA-2023-N-2177-7077", "FDA", "FDA-2023-N-2177", "Reference 227 - Simner, et al., \u201cRaising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:44:28Z", null, 0, 0, "090000648652d38a"], ["FDA-2023-N-2177-6863", "FDA", "FDA-2023-N-2177", "Reference 13 - Alliance for a Stronger FDA, \u201cThe US Food and Drug Administration: A Cornerstone of America\u2019s Economic Future\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T15:39:57Z", null, 0, 0, "090000648652057e"], ["FDA-2023-N-2177-6898", "FDA", "FDA-2023-N-2177", "Reference 48 - Health Resources and Services Administration, \u201cOrgan Procurement and Transplantation Network, Policies,\u201d Effective as of April 2, 2024", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T15:52:44Z", null, 0, 0, "0900006486523c23"], ["FDA-2023-N-2177-6914", "FDA", "FDA-2023-N-2177", "Reference 64 - FDA, \u201cLabeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:11:25Z", null, 0, 0, "09000064865291a0"], ["FDA-2023-N-2177-6924", "FDA", "FDA-2023-N-2177", "Reference 74 - CDC, \u201cClinical Laboratory Improvement Advisory Committee Summary Report,\u201d April 12-13, 2023", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:13:39Z", null, 0, 0, "090000648652920d"], ["FDA-2023-N-2177-6925", "FDA", "FDA-2023-N-2177", "Reference 75 - FDA, \u201cThe Least Burdensome Provisions: Concept and Principles; Guidance for Industry and FDA Staff\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:13:47Z", null, 0, 0, "090000648652920e"], ["FDA-2023-N-2177-6929", "FDA", "FDA-2023-N-2177", "Reference 79 - Association for Molecular Pathology, \u201cClinical Practice \u2013 Practice Guidelines\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:14:19Z", null, 0, 0, "0900006486529291"], ["FDA-2023-N-2177-6947", "FDA", "FDA-2023-N-2177", "Reference 97 - FDA, \u201cGenetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:17:26Z", null, 0, 0, "0900006486529374"], ["FDA-2023-N-2177-6951", "FDA", "FDA-2023-N-2177", "Reference 101 - Merker, et al., \u201cProficiency Testing of Standardized Samples Shows Very High Interlaboratory Agreement for Clinical Next-Generation Sequencing\u2013Based Oncology Assays\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:18:18Z", null, 0, 0, "0900006486529a15"], ["FDA-2023-N-2177-6954", "FDA", "FDA-2023-N-2177", "Reference 104 - Zhang, et al., \u201cAn Overview of Characteristics of Clinical Next-Generation Sequencing\u2013Based Testing for Hematologic Malignancies\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:18:40Z", null, 0, 0, "0900006486529a18"], ["FDA-2023-N-2177-6960", "FDA", "FDA-2023-N-2177", "Reference 110 - Damon, \u201cThe COVID Testing Company That Missed 96% of Cases,\u201d ProPublica, May 16, 2022", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:19:25Z", null, 0, 0, "0900006486529a82"], ["FDA-2023-N-2177-6913", "FDA", "FDA-2023-N-2177", "Reference 63 - International Society of Blood Transfusion, \u201cRed Cell Immunogenetics and Blood Group Terminology\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:11:17Z", null, 0, 0, "0900006486528f9e"], ["FDA-2023-N-2177-6928", "FDA", "FDA-2023-N-2177", "Reference 78 - College of American Pathologists, \u201cLaboratory Accreditation: Guide to CAP Accreditation,\u201d 2018", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:14:11Z", null, 0, 0, "0900006486529290"], ["FDA-2023-N-2177-6934", "FDA", "FDA-2023-N-2177", "Reference 84 - Washington State Department of Health, \u201cMedical Test Sites (MTS) State Authority and Responsibilities\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:15:20Z", null, 0, 0, "09000064865292de"], ["FDA-2023-N-2177-6940", "FDA", "FDA-2023-N-2177", "Reference 90 - Wittrock, et al., \u201cImplementing Responsible Research and Innovation: Organisational and National Conditions\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:16:08Z", null, 0, 0, "0900006486529351"], ["FDA-2023-N-2177-6972", "FDA", "FDA-2023-N-2177", "Reference 122 - Greely, \u201cThe Future of DTC Genomics and the Law\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:21:23Z", null, 0, 0, "0900006486529c22"], ["FDA-2023-N-2177-6976", "FDA", "FDA-2023-N-2177", "Reference 126 - Merriam-Webster, Contrivance", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:22:27Z", null, 0, 0, "0900006486529cb7"], ["FDA-2023-N-2177-6983", "FDA", "FDA-2023-N-2177", "Reference 133 - FDA, \u201cCompliance Policy Guide (CPG) Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:23:27Z", null, 0, 0, "0900006486529da9"], ["FDA-2023-N-2177-6996", "FDA", "FDA-2023-N-2177", "Reference 146 - FDA, De Novo Decision Summary, Adaptive Biotechnologies ClonoSEQ Assay, DEN170080, Decision Date September 28, 2018", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:25:46Z", null, 0, 0, "0900006486529eb6"], ["FDA-2023-N-2177-7009", "FDA", "FDA-2023-N-2177", "Reference 159 - FDA, \u201cResponding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Draft Guidance,\u201d December 2011", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:28:47Z", null, 0, 0, "0900006486529efe"], ["FDA-2023-N-2177-6872", "FDA", "FDA-2023-N-2177", "Reference 22 - AdvaMed, \u201cPress Release: In Congressional Testimony, AdvaMed Urges Passage of Diagnostic Regulatory Reform\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T15:45:16Z", null, 0, 0, "090000648652293c"], ["FDA-2023-N-2177-6890", "FDA", "FDA-2023-N-2177", "Reference 40 - FDA, \u201cDirect-to-Consumer Tests\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T15:49:04Z", null, 0, 0, "0900006486523a44"], ["FDA-2023-N-2177-6989", "FDA", "FDA-2023-N-2177", "Reference 139 - Merriam-Webster, Distribute", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:24:29Z", null, 0, 0, "0900006486529e4d"], ["FDA-2023-N-2177-6889", "FDA", "FDA-2023-N-2177", "Reference 39 - 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McKnight and Hinton, \"Tort Costs in America: An Empirical Analysis of Costs and Compensation of the U.S. Tort System\"", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T22:02:18Z", null, 0, 0, "090000648652e391"], ["FDA-2023-N-2177-7045", "FDA", "FDA-2023-N-2177", "Reference 195 - FDA, 510(k) Substantial Equivalence Determination Decision Summary, BD Respiratory Viral Panel (BD RVP) for BD MAX System; BD Respiratory Viral Panel-SCV2 (BD RVP-SCV2) for BD MAX System, K230956, Decision Date July 31, 2023", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:36:46Z", null, 0, 0, "090000648652c9c4"], ["FDA-2023-N-2177-7059", "FDA", "FDA-2023-N-2177", "Reference 209 - Harpool, \u201cHow Academic Medical Centers can Innovate During Tough Times\u201d", "Supporting & Related Material", "Background Material", "2024-05-06T04:00:00Z", 2024, 5, null, null, "2024-05-06T16:39:30Z", null, 0, 0, "090000648652d321"], ["FDA-2023-N-2177-7066", "FDA", "FDA-2023-N-2177", "Reference 216 - 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