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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 10 Results
productcode OWD PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
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PMA
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COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S009 09/12/2013
COBAS EGFR MUTATION TEST ROCHE P120019 S003 09/12/2013
COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S008 09/06/2013
COBAS EGFR MUTATION TEST ROCHE P120019 S002 09/06/2013
COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S007 08/21/2013
COBAS EGFR MUTATION TEST ROCHE P120019 S001 08/21/2013
THERASCREEN EGFR RGQ PCR KIT QIAGEN GmbH P120022 07/12/2013
BIOMERIEUX THXID BRAF ASSAY KIT bioMerieux, Inc. P120014 05/29/2013
COBAS EGFR MUTATION TEST ROCHE P120019 05/14/2013
ROCHE COBAS DNA SAMPLE PREPARATION KIT,05985553619... Roche Molecular Systems, Inc. P110020 S006 01/10/2013
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