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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 16 Results
productcode OWD PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Abbott RealTime IDH1 Assay Abbott Molecular, Inc. P170041 S002 11/12/2019
cobas BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S034 10/10/2019
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S030 10/10/2019
cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S021 10/10/2019
therascreen EGFR RGQ PCR Kit QIAGEN GmbH P120022 S020 09/26/2019
cobas 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S033 09/25/2019
cobas EGFR Mutation Test v2 ROCHE P120019 S029 09/25/2019
RealTime IDH2 Abbott Molecular Inc. P170005 S001 09/24/2019
RealTime IDH1 Abbott Molecular, Inc. P170041 S001 09/24/2019
THxID BRAF assay kit bioMerieux, Inc. P120014 S009 08/26/2019
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