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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 21 Results
productcode OWD PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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PMA
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THxID-BRAF kit bioMerieux, Inc. P120014 S007 11/22/2016
Roche cobas DNA Sample Preparation Kit, COBAS 4800... Roche Molecular Systems, Inc. P110020 S016 11/07/2016
cobas EGFR Mutation Test and cobas® EGFR Mutation ... ROCHE P120019 S012 10/19/2016
COBAS KRAS MUTATION TEST Roche Molecular Systems, Inc. P140023 S008 10/19/2016
Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150047 S002 10/19/2016
cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150044 09/28/2016
COBAS KRAS MUTATION TEST Roche Molecular Systems, Inc. P140023 S004 09/24/2016
COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020 S018 09/20/2016
COBAS EGFR MUTATION TEST ROCHE P120019 S011 09/20/2016
COBAS KRAS MUTATION TEST Roche Molecular Systems, Inc. P140023 S007 09/20/2016
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