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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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PMA
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DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 07/05/2001
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S008 07/11/2005
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S009 01/04/2007
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S010 09/14/2007
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S011 03/13/2008
TPSA FLEX REAGENT SIEMENS HEALTHCARE DIAGNOSTICS P000021 S012 03/14/2008
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S013 05/19/2010
DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S014 06/04/2009
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S015 05/27/2010
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S016 04/26/2010
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