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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant SIEMENS HEALTHCARE DIAGNOSTICS productcode MTF
 
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PMA
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Dimension® TPSA Flex® reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S045 09/26/2023
IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA ... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S028 10/14/2022
IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMM... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S026 03/29/2022
Dimension® TPSA Flex® reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S044 12/20/2021
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
Dimension Vista TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S043 10/13/2020
IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULI... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S024 09/08/2020
ADVIA Centaur PSA Readypack Reagents SIEMENS HEALTHCARE DIAGNOSTICS P950021 S022 08/25/2020
IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S023 08/18/2020
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