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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 Decision Date To 04/25/2024
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Device
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PMA
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DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S014 06/04/2009
ADVIA CENTAUR PSA ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P950021 S010 03/06/2009
IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S007 12/30/2008
TPSA FLEX REAGENT SIEMENS HEALTHCARE DIAGNOSTICS P000021 S012 03/14/2008
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S011 03/13/2008
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S010 09/14/2007
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S009 01/04/2007
ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSA... SIEMENS HEALTHCARE DIAGNOSTICS P950021 S008 11/06/2006
ADVIA CENTAUR CP PSA ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P950021 S007 10/07/2005
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S008 07/11/2005
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