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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 MTG PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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Dimension Vista FPSA Flex reagent cartridge (K6452... SIEMENS HEALTHCARE DIAGNOSTICS P020027 S030 12/15/2017
Dimension Vista FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S029 11/14/2017
Access Hybritech free PSA Reagents/Calibrator Kit ... BECKMAN COULTER, INC. P970038 S036 10/24/2017
Dimension FPSA Flex reagent cartridge (RF451) SIEMENS HEALTHCARE DIAGNOSTICS P020027 S027 07/17/2017
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S034 07/07/2017
Access Hybritech Free PSA Reagents on the Access I... BECKMAN COULTER, INC. P970038 S033 06/16/2017
Dimension FPSA Flex reagent cartridge (RF452) SIEMENS HEALTHCARE DIAGNOSTICS P020027 S026 05/22/2017
Dimension FPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P020027 S025 03/16/2017
ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOAS... BECKMAN COULTER, INC. P970038 S032 02/14/2017
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