Regulations.gov document

Draft Guidance for Industry: Recommendations for Premarket Notification (510(k))…

Notice · FDA-2013-D-1358 · posted Nov 20, 2013

Key facts

Document ID FDA-2013-D-1358-0001
Title Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of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
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2013-D-1358
Posted Nov 20, 2013
Federal Register citation 78 FR 69693
FR document number 2013-27774
Comment period opens Nov 20, 2013
Comments due Feb 19, 2014
Effective date Nov 20, 2013

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