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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode MTG PMA Number p Decision Date From 1/1/2010 Decision Date To 1/1/2011
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PMA
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DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S014 12/13/2010
AXSYM FREE PSA (LN 3C20) Abbott Laboratories P980007 S012 10/20/2010
DIMENSIONS FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S012 09/02/2010
ARCHITECT FREE PSA ASSAY Abbott Laboratories P980007 S010 08/31/2010
ELECSYS FREE PSA CALCHECK ROCHE DIAGNOSTICS CORP. P000027 S008 06/08/2010
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S010 05/27/2010
FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S009 05/17/2010
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S011 04/26/2010
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S003 01/21/2010
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