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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 17 Results
productcode OWD PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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cobas 4800 braf v600 mutation test Roche Molecular Systems, Inc. P110020 S023 11/13/2017
cobas egfr mutation test and cobas egfr v2 mutatio... ROCHE P120019 S017 11/13/2017
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S012 11/13/2017
roche cobas kras mutation test /roche cobas dna sa... Roche Molecular Systems, Inc. P140023 S011 10/16/2017
roche cobas dna sample preparation kit / roche cob... Roche Molecular Systems, Inc. P110020 S022 10/13/2017
roche cobas egfr mutation test / roche cobas dna s... ROCHE P120019 S015 10/13/2017
cobas 4800 braf v600 mutation test Roche Molecular Systems, Inc. P110020 S021 08/15/2017
cobas egfr mutation test v2 ROCHE P120019 S014 08/15/2017
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S010 08/15/2017
cobas 4800 braf v600 mutation test Roche Molecular Systems, Inc. P110020 S020 08/11/2017
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