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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 LTJ PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
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Elecsys free PSA ROCHE DIAGNOSTICS CORP. P000027 S028 12/20/2017
Dimension Vista TPSA Flex reagent cartridge (K6451... SIEMENS HEALTHCARE DIAGNOSTICS P000021 S035 12/15/2017
Dimension Vista TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S034 11/14/2017
Elecsys Free PSA Immunoassay ROCHE DIAGNOSTICS CORP. P000027 S026 08/31/2017
Dimension TPSA Flex reagent cartridge (RF451) SIEMENS HEALTHCARE DIAGNOSTICS P000021 S032 07/17/2017
Elecsys free PSA Immunoassay ROCHE DIAGNOSTICS CORP. P000027 S025 06/23/2017
Dimension TPSA Flex reagent cartridge (RF451) SIEMENS HEALTHCARE DIAGNOSTICS P000021 S031 05/22/2017
Dimension TPSA Flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S030 03/16/2017
Elecsys free PSA, free PSA Calset, free PSA CalChe... ROCHE DIAGNOSTICS CORP. P000027 S023 03/02/2017
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