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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 1/1/2018 Decision Date To 1/1/2019
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PMA
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Dimension Vista FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S034 12/27/2018
IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 ... SIEMENS MEDICAL SOLUTIONS DIAG P060005 S009 12/27/2018
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S037 12/21/2018
Elecsys free PSA, free PSA CalSet, and free PSA Ca... ROCHE DIAGNOSTICS CORP. P000027 S027 07/27/2018
Dimension Vista FPSA Flex reagent cartridge (K6452... SIEMENS HEALTHCARE DIAGNOSTICS P020027 S033 07/05/2018
Dimension FPSA Flex Reagent Cartidge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S032 05/14/2018
Dimension FPSA Flex Reagent Cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S028 04/13/2018
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