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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode OWD PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
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Device
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PMA
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Decision
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THXID BRAF KIT bioMerieux, Inc. P120014 S002 12/22/2014
THERASCREEN EGFR RGQ PCR KIT QIAGEN GmbH P120022 S002 12/19/2014
THERASCREEN KRAS RGQ PCR KIT QIAGEN GmbH P110027 05/23/2014
COBAS BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S010 03/12/2014
COBAS EGFR MUTATION TEST ROCHE P120019 S004 03/12/2014
COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S011 01/09/2014
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