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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 36 Results
productcode OWD PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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LeukoStrat CDx FLT3 Mutation Assay INVIVOSCRIBE TECHNOLOGIES, INC P160040 S004 12/21/2018
cobas BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S031 12/13/2018
cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S019 12/13/2018
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S026 12/11/2018
cobas BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S030 12/07/2018
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S025 12/07/2018
cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S018 12/07/2018
LeukoStrat CDx FLT3 Mutation Assay INVIVOSCRIBE TECHNOLOGIES, INC P160040 S003 12/07/2018
LeukoStrat CDx FLT3 Mutation Assay INVIVOSCRIBE TECHNOLOGIES, INC P160040 S002 11/28/2018
therascreen EGFR RGQ PCR Kit QIAGEN GmbH P120022 S018 09/27/2018
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