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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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