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FDA PMA Number P970038, Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
FDA PMA Number P970038, Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
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PMA Number: P970038
Device: Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Generic Name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Manufacturer: BECKMAN COULTER, INC.
Product Code: MTG
Date Received: 09/30/2020
Decision Date: 12/16/2020
Notice Date: 01/00/1900
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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