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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 17 Results
productcode MTG PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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ELECSYS FREE PSA ROCHE DIAGNOSTICS CORP. P000027 S014 12/18/2012
ARCHITECT FREE PSA AND AXSYM FREE PSA Abbott Laboratories P980007 S027 12/11/2012
ARCHITECT FREE PSA Abbott Laboratories P980007 S028 12/07/2012
ARCHITECT FREE PSA Abbott Laboratories P980007 S029 12/07/2012
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S019 11/20/2012
ACCESS HYBRITECH FREE PSA REAGENT ON THE ACCESS IM... BECKMAN COULTER, INC. P970038 S017 11/19/2012
IMMULITE FPSA ASSAY SIEMENS MEDICAL SOLUTIONS DIAG P060005 S008 11/08/2012
ARCHITECT FREE PSA Abbott Laboratories P980007 S026 08/29/2012
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S016 04/13/2012
FPSA IMMULITE SUBSTRATE REAGENT SIEMENS MEDICAL SOLUTIONS DIAG P060005 S007 04/05/2012
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