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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode MTF PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
 
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ACCESS HYBRITECH PSA ASSAY BECKMAN COULTER, INC. P850048 S038 12/23/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S046 12/11/2014
ARCHITECT TOTAL PSA (LN 6CO6) Abbott Laboratories P910007 S047 12/08/2014
IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT SIEMENS HEALTHCARE DIAGNOSTICS P930027 S016 12/02/2014
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S039 10/24/2014
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S026 09/25/2014
ARCHITECT TOTAL PSA (LN 6C06) Abbott Laboratories P910007 S045 06/18/2014
ELECSYS TOTAL PSA ROCHE DIAGNOSTICS CORP. P990056 S021 06/12/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S044 05/28/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S043 05/16/2014
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