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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 31 Results
productcode OWD PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
 
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PMA
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COBAS EGFR MUTATION TEST V2 ROCHE P120019 S007 11/13/2015
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S009 11/09/2015
THERASCREEN EGFR RGQ PCR KIT QIAGEN GmbH P120022 S012 11/09/2015
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA... Roche Molecular Systems, Inc. P140023 S002 09/24/2015
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 S008 08/06/2015
THERASCREEN EGFR RGQ PCR KIT QIAGEN GmbH P120022 S010 08/06/2015
ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBA... Roche Molecular Systems, Inc. P110020 S014 07/23/2015
ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SA... ROCHE P120019 S008 07/23/2015
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SA... Roche Molecular Systems, Inc. P140023 S001 07/23/2015
THERASCEEN EGFR RGQ PCR KIT QIAGEN GmbH P120022 S001 07/10/2015
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