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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 10 Results
productcode MTF PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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PMA
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IMMULITE 2000 PSA SIEMENS HEALTHCARE DIAGNOSTICS P930027 S022 12/19/2019
Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S052 08/09/2019
Access Hybritech PSA Reagents on the Access Immuno... BECKMAN COULTER, INC. P850048 S051 07/31/2019
IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & ... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S021 07/11/2019
Dimension Vista TPSA Flex reagent cartridge (K6451... SIEMENS HEALTHCARE DIAGNOSTICS P000021 S041 06/26/2019
Dimension TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S040 06/20/2019
AIA-PACK PSA TOSOH BIOSCIENCE, INC. P910065 S009 06/18/2019
Elecsys total PSA Test System ROCHE DIAGNOSTICS CORP. P990056 S036 05/03/2019
Elecsys total PSA ROCHE DIAGNOSTICS CORP. P990056 S035 04/24/2019
Sangia Total PSA Test OPKO Diagnostics, LLC. P170037 01/30/2019
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