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withdrawn,object_id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-2013-D-1358-0009,FDA,FDA-2013-D-1358,Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Other,Guidance,2015-08-03T04:00:00Z,2015,8,2015-08-03T04:00:00Z,,2024-11-12T05:40:35Z,,1,0,0900006481bba982
FDA-2013-D-1358-0014,FDA,FDA-2013-D-1358,Reference 15 - Clinical Relevance of the HLA System in Blood Transfusion (2)  re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:03:01Z,,0,0,0900006481bbb8d5
FDA-2013-D-1358-0012,FDA,FDA-2013-D-1358,Reference 13 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:02:47Z,,0,0,0900006481bbbbd0
FDA-2013-D-1358-0016,FDA,FDA-2013-D-1358,Reference 17 - The HLA System (Part II) (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:03:13Z,,0,0,0900006481bbb8d7
FDA-2013-D-1358-0010,FDA,FDA-2013-D-1358,List of References re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:02:31Z,,0,0,0900006481bbbbcd
FDA-2013-D-1358-0008,FDA,FDA-2013-D-1358,"Recommendations for Premarket Notification (510(k)) Submissions for
Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability",Notice,Notice of Availability,2015-08-03T04:00:00Z,2015,8,2015-08-03T04:00:00Z,,2015-08-03T16:05:21Z,2015-18956,0,0,0900006481bb9559
FDA-2013-D-1358-0015,FDA,FDA-2013-D-1358,Reference 16 - The HLA System (Part I) (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:03:07Z,,0,0,0900006481bbb8d6
FDA-2013-D-1358-0017,FDA,FDA-2013-D-1358,Reference 18 - The Human Leukocyte Antigen System (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:03:23Z,,0,0,0900006481bbb8d8
FDA-2013-D-1358-0011,FDA,FDA-2013-D-1358,Reference 9- IMGT Home page re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:02:40Z,,0,0,0900006481bbbbcf
FDA-2013-D-1358-0013,FDA,FDA-2013-D-1358,Reference 14 - Interference Testing in Clinical Chemistry; Approved Guideline (2) re Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Supporting & Related Material,Background Material,2015-08-03T04:00:00Z,2015,8,,,2015-08-03T19:02:53Z,,0,0,0900006481bbbbd1
FDA-2013-D-1358-0001,FDA,FDA-2013-D-1358,Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability,Notice,Notice of Availability,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,2014-02-19T04:59:59Z,2015-07-13T17:54:08Z,2013-27774,0,0,090000648148bc0a
FDA-2013-D-1358-0002,FDA,FDA-2013-D-1358,Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation,Other,Guidance,2013-11-20T05:00:00Z,2013,11,2013-11-20T05:00:00Z,,2024-11-12T05:24:15Z,,1,0,090000648148c493