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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 25 Results
productcode MTG PMA Number p Decision Date From 1/1/2011 Decision Date To 1/1/2012
 
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Device
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PMA
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AXSYM FREE PSA (LN 3C20) Abbott Laboratories P980007 S023 12/22/2011
ELECSYS FREE PSA IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P000027 S013 12/21/2011
ARCHITECT FREE PSA Abbott Laboratories P980007 S024 12/21/2011
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S016 12/15/2011
DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR US... SIEMENS HEALTHCARE DIAGNOSTICS P020027 S015 11/23/2011
ELECSYS FREE PSA IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P000027 S011 09/23/2011
AXSYM FREE PSA & ARCHITECT FREE PSA Abbott Laboratories P980007 S022 09/13/2011
IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 ... SIEMENS MEDICAL SOLUTIONS DIAG P060005 S006 09/12/2011
FPSA IMMULITE ASSAY SIEMENS MEDICAL SOLUTIONS DIAG P060005 S005 09/07/2011
ARCHITECT FREE PSA Abbott Laboratories P980007 S013 07/26/2011
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