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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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31 to 40 of 73 Results
Applicant SIEMENS HEALTHCARE DIAGNOSTICS productcode MTF Decision Date To 04/25/2024
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Device
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PMA
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IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA SIEMENS HEALTHCARE DIAGNOSTICS P930027 S017 03/21/2017
Dimension TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S030 03/16/2017
DIMENSION VISTA TPSA ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P000021 S028 10/19/2016
DIMENSION TPSA FLEX REAGENT CARTRIDGE (RF451) SIEMENS HEALTHCARE DIAGNOSTICS P000021 S029 08/30/2016
DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION... SIEMENS HEALTHCARE DIAGNOSTICS P000021 S027 12/15/2015
IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT SIEMENS HEALTHCARE DIAGNOSTICS P930027 S016 12/02/2014
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S026 09/25/2014
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S025 05/28/2013
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S023 02/22/2013
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S024 11/20/2012
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