Regulations.gov document

Reference 13 - Evaluation of Precision Performance of Quantitative Measurement Methods…

Supporting & Related Material · FDA-2013-D-1358 · posted Aug 3, 2015

Key facts

Document ID FDA-2013-D-1358-0012
Title 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
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2013-D-1358
Posted Aug 3, 2015

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