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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 LTJ PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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dimension vista tpsa flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S039 12/27/2018
elecsys free psa test system ROCHE DIAGNOSTICS CORP. P000027 S032 10/25/2018
dimension vista tpsa flex reagent cartridge (k6451... SIEMENS HEALTHCARE DIAGNOSTICS P000021 S038 07/05/2018
elecsys free psa ROCHE DIAGNOSTICS CORP. P000027 S031 06/13/2018
dimension tpsa flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S037 05/14/2018
elecsys free psa ROCHE DIAGNOSTICS CORP. P000027 S030 04/20/2018
dimension tpsa flex reagent cartridge SIEMENS HEALTHCARE DIAGNOSTICS P000021 S033 04/13/2018
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