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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 7 of 7 Results
productcode MTG 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 FPSA FLEX REAGENT CARTRIDGE AND DIMENSIO... SIEMENS HEALTHCARE DIAGNOSTICS P020027 S022 12/15/2015
ELECSYS FREE PSA IMMUNOASSAY ROCHE DIAGNOSTICS CORP. P000027 S021 11/24/2015
ARCHITECT FREE PSA (LN 6C07) Abbott Laboratories P980007 S040 08/13/2015
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS I... BECKMAN COULTER, INC. P970038 S031 06/23/2015
ACCESS HYBRITECH FREE PSA REAGENT ASSAY BECKMAN COULTER, INC. P970038 S030 06/09/2015
ARCHITECT FREE PSA (LN 6C07) Abbott Laboratories P980007 S039 03/26/2015
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT BECKMAN COULTER, INC. P970038 S029 03/20/2015
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