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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode OWD PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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therascreen KRAS RGQ PCR Kit QIAGEN GmbH P110027 S013 12/12/2022
Abbott RealTime IDH1, Abbott RealTime IDH1 Amplifi... Abbott Molecular, Inc. P170041 S006 12/01/2022
cobas® BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S036 11/29/2022
cobas® EGFR Mutation Test ROCHE P120019 S033 11/29/2022
cobas® BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S037 11/14/2022
cobas® EGFR Mutation Test, v2.0 ROCHE P120019 S034 11/14/2022
cobas® KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S025 11/14/2022
therascreen KRAS RGQ PCR Kit QIAGEN GmbH P110027 S015 07/11/2022
therascreen KRAS RGQ PCR Kit QIAGEN GmbH P110027 S014 06/17/2022
Abbott RealTime IDH1 Abbott Molecular, Inc. P170041 S004 06/02/2022
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