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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 17 of 17 Results
productcode MTG 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 FREE PSA ROCHE DIAGNOSTICS CORP. P000027 S015 03/28/2012
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S017 03/22/2012
ARCHITECT FREE PSA Abbott Laboratories P980007 S025 03/22/2012
DIMENSION FPSA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS P020027 S018 03/16/2012
ELECSYS FREE PSA (FPSA) TEST SYSTEM ROCHE DIAGNOSTICS CORP. P000027 S012 02/24/2012
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNO... BECKMAN COULTER, INC. P970038 S015 02/17/2012
VIDAS FREE PSA (FPSA) ASSAY bioMerieux, Inc. P080008 S001 02/08/2012
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