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Draft Guidance for Industry: Recommendations for Premarket Notification (510(k))…

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

Key facts

Document ID FDA-2013-D-1358-0002
Title Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of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
Document type Other
Subtype Guidance
Agency FDA
Docket FDA-2013-D-1358
Posted Nov 20, 2013
Comment period opens Nov 20, 2013

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