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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode MTF PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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PMA
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DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION... SIEMENS HEALTHCARE DIAGNOSTICS P000021 S027 12/15/2015
ELECSYS TOTAL PSA IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P990056 S022 11/24/2015
ARCHITECT TOTAL PSA (LN 6C06) Abbott Laboratories P910007 S049 08/13/2015
VIDAS TOTAL PSA ASSAY bioMerieux, Inc. P040008 S012 08/05/2015
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P850048 S041 06/23/2015
VIDAS TOTAL PSA bioMerieux, Inc. P040008 S011 04/22/2015
ARCHITECT TOTAL PSA (LN 6C06) Abbott Laboratories P910007 S048 03/26/2015
ACCESS HYBRITECH PSA ASSAY BECKMAN COULTER, INC. P850048 S040 03/20/2015
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