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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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 Abbott Laboratories P980007 S014 05/20/2011
ARCHITECT FREE PSA Abbott Laboratories P980007 S013 07/26/2011
ARCHITECT FREE PSA Abbott Laboratories P980007 S011 03/31/2011
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S014 02/04/2011
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S013 02/07/2011
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
IMMULITE/IMMULITE 2000 FREE PSA SIEMENS MEDICAL SOLUTIONS DIAG P060005 S004 04/26/2011
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
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