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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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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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