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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 17 Results
productcode OWD PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Cobas 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S023 11/13/2017
Cobas EGFR Mutation Test and Cobas EGFR v2 Mutatio... ROCHE P120019 S017 11/13/2017
Cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S012 11/13/2017
Roche cobas KRAS Mutation Test /Roche cobas DNA Sa... Roche Molecular Systems, Inc. P140023 S011 10/16/2017
Roche cobas DNA Sample Preparation Kit / Roche cob... Roche Molecular Systems, Inc. P110020 S022 10/13/2017
Roche cobas EGFR Mutation Test / Roche cobas DNA S... ROCHE P120019 S015 10/13/2017
cobas 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S021 08/15/2017
cobas EGFR Mutation Test v2 ROCHE P120019 S014 08/15/2017
cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S010 08/15/2017
COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S020 08/11/2017
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