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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode MTF PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Dimension® TPSA Flex® reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S044 12/20/2021
ARCHITECT Total PSA / Alinity i Total PSA Abbott Laboratories P910007 S057 12/15/2021
ARCHITECT Total PSA (LN 6C06) Abbott Laboratories P910007 S056 12/06/2021
Elecsys total PSA Test System ROCHE DIAGNOSTICS CORP. P990056 S038 11/16/2021
Dimension Vista TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S042 10/08/2021
IMMULITE/IMMULITE 1000 THIRD GENERATION PSA SIEMENS HEALTHCARE DIAGNOSTICS P930027 S025 04/28/2021
ARCHITECT Total PSA Reagent Kit, Alinity i Total P... Abbott Laboratories P910007 S055 04/22/2021
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