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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode MTG PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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IMMULITE 2000 Free PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S010 12/19/2019
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S040 08/09/2019
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S039 07/31/2019
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atelli... SIEMENS HEALTHCARE DIAGNOSTICS P950021 S018 07/25/2019
Dimension Vista TPSA Flex reagent cartridge (K6452... SIEMENS HEALTHCARE DIAGNOSTICS P020027 S036 06/26/2019
Dimension FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S035 06/20/2019
Elecsys free PSA Test System ROCHE DIAGNOSTICS CORP. P000027 S034 05/03/2019
Elecsys free PSA ROCHE DIAGNOSTICS CORP. P000027 S033 04/24/2019
Atellica IM Prostate-Specific Antigen (PSA) Assay SIEMENS HEALTHCARE DIAGNOSTICS P950021 S017 03/08/2019
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