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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode MTF PMA Number p Decision Date From 1/1/2008 Decision Date To 1/1/2009
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IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500... SIEMENS HEALTHCARE DIAGNOSTICS P930027 S007 12/30/2008
ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PS... ROCHE DIAGNOSTICS CORP. P990056 S007 11/18/2008
ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUN... ROCHE DIAGNOSTICS CORP. P990056 S008 10/17/2008
VIDAS TOTAL PSA (TPSA) ASSAY bioMerieux, Inc. P040008 S001 09/25/2008
ELECSYS TOTAL PSA ROCHE DIAGNOSTICS CORP. P990056 S009 09/17/2008
ACCESS HYBRITECH PSA WHO STANDARDIZATION BECKMAN COULTER, INC. P850048 S021 05/09/2008
TPSA FLEX REAGENT SIEMENS HEALTHCARE DIAGNOSTICS P000021 S012 03/14/2008
DIMENSION TPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P000021 S011 03/13/2008
ACCESS HYBRITECH PSA IMMUNOASSAY BECKMAN COULTER, INC. P850048 S023 02/26/2008
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