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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 24 Results
productcode OWD PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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therascreen FGFR RGQ RT-PCR Kit QIAGEN GmbH P180043 S006 12/22/2023
Roche cobas BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S041 12/21/2023
Roche cobas EFGR Mutation Test, v2.0 ROCHE P120019 S038 12/21/2023
Roche cobas KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S028 12/21/2023
Roche cobas® EZH2 Mutation Test Roche Molecular System, Inc. P200014 S008 12/21/2023
cobas® BRAF V600 Mutation Test Roche Molecular Systems, Inc. P110020 S040 12/14/2023
cobas® EGFR Mutation Test, v2.0 ROCHE P120019 S037 12/14/2023
cobas® KRAS Mutation Test Roche Molecular Systems, Inc. P140023 S027 12/14/2023
cobas® EZH2 Mutation Test Roche Molecular System, Inc. P200014 S007 12/14/2023
Abbott RealTime IDH1 Abbott Molecular, Inc. P170041 S007 10/24/2023
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