FDA PMA Number P970038, Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

Contents: A copy of PMA Supplement P970038/S044; 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 etc.

Request Year: 2023

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