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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 19 Results
productcode MTF PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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PMA
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ELECSYS TOTAL PSA CALSET ROCHE DIAGNOSTICS CORP. P990056 S019 12/26/2012
ELECSYS TOTAL PSA ROCHE DIAGNOSTICS CORP. P990056 S016 12/18/2012
ARCHITECT TOTAL PSA AND AXSYM TOTAL PSA Abbott Laboratories P910007 S036 12/11/2012
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S037 12/07/2012
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S038 12/07/2012
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S024 11/20/2012
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S028 11/19/2012
IMMULITE PSA ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P930027 S015 11/08/2012
ADVIA CENTAUR PSA ASSAY SIEMENS HEALTHCARE DIAGNOSTICS P950021 S013 10/15/2012
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S035 08/29/2012
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