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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 14 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 REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S037 05/01/2014
ELECSYS TOTAL PSA IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P990056 S020 03/21/2014
VIDAS TOTAL PSA (TPSA) ASSAY bioMerieux, Inc. P040008 S008 03/06/2014
ARCHITECT TOTAL PSA Abbott Laboratories P910007 S042 02/03/2014
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