id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2025-N-1243-0003,FDA,FDA-2025-N-1243,"Reference 1 - In Vitro Companion Diagnostic Devices – Guidance for Industry and Food and Drug Administration Staff, issued August 6, 2014",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:34:01Z,,0,0,09000064b8dee62b
FDA-2025-N-1243-0004,FDA,FDA-2025-N-1243,Reference 2 - P980024/S001 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:08Z,,0,0,09000064b8dee62c
FDA-2025-N-1243-0008,FDA,FDA-2025-N-1243,Reference 6 - P100024 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:48Z,,0,0,09000064b8df61ae
FDA-2025-N-1243-0011,FDA,FDA-2025-N-1243,Reference 9 - P150041 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:36:19Z,,0,0,09000064b8df61b8
FDA-2025-N-1243-0015,FDA,FDA-2025-N-1243,"Reference 13 - Manning JE, Hershey ND, Broker TR, Pellegrini M, Mitchell HK, Davidson N. A new method of in situ hybridization",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:37:35Z,,0,0,09000064b8df61bf
FDA-2025-N-1243-0001,FDA,FDA-2025-N-1243,Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product,Proposed Rule,Request for Comment,2025-06-11T04:00:00Z,2025,6,2025-06-11T04:00:00Z,2025-08-12T03:59:59Z,2025-08-12T09:00:21Z,2025-10549,0,0,09000064b8ded24e
FDA-2025-N-1243-0005,FDA,FDA-2025-N-1243,"Reference 3 - “Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997,” issued on August 9, 2000",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:18Z,,0,0,09000064b8df619f
FDA-2025-N-1243-0006,FDA,FDA-2025-N-1243,Reference 4 - P040005 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:28Z,,0,0,09000064b8df61a4
FDA-2025-N-1243-0009,FDA,FDA-2025-N-1243,Reference 7 - P100027 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:57Z,,0,0,09000064b8df61b4
FDA-2025-N-1243-0012,FDA,FDA-2025-N-1243,"Reference 10 - Curtin, SC, Tejada-Vera, B, Bastian, Deaths: Leading Causes for 2021. National Center for Health Statistics. Vital Health Stat 73(4). 2024",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:36:44Z,,0,0,09000064b8df61ba
FDA-2025-N-1243-0016,FDA,FDA-2025-N-1243,"Reference 14 - Bauman JG, Wiegant J, Borst P, van Duijn P. A new method for fluorescence microscopical localization of specific DNA sequences by in situ hybridization of fluorochromelabelled RNA",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:37:59Z,,0,0,09000064b8df61c1
FDA-2025-N-1243-0010,FDA,FDA-2025-N-1243,Reference 8 - P110012 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:36:10Z,,0,0,09000064b8df61b6
FDA-2025-N-1243-0013,FDA,FDA-2025-N-1243,"Reference 11- Chu YH, Hardin H, Zhang R, Guo Z, Lloyd RV. In situ hybridization: Introduction to techniques, applications and pitfalls in the performance and interpretation of assays",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:37:00Z,,0,0,09000064b8df61bd
FDA-2025-N-1243-0007,FDA,FDA-2025-N-1243,Reference 5 - P050040 Summary of Safety and Effectiveness,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:35:40Z,,0,0,09000064b8df61a7
FDA-2025-N-1243-0002,FDA,FDA-2025-N-1243,List of References,Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:33:51Z,,0,0,09000064b8dee629
FDA-2025-N-1243-0014,FDA,FDA-2025-N-1243,"Reference 12 - du Sart, D., Andy Choo, K.H. (1998). The Technique of In Situ Hybridization. In: Rapley, R., Walker, J.M. (eds) Molecular Biomethods Handbook. Springer Protocols Handbooks",Supporting & Related Material,Background Material,2025-06-11T04:00:00Z,2025,6,,,2025-06-11T23:37:27Z,,0,0,09000064b8df61be