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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 91 Results
Applicant: ROCHE Product Code: OWD Decision Date to 10/14/2019
 
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cobas braf v600 mutation test Roche Molecular Systems, Inc. P110020 S034 10/10/2019
cobas egfr mutation test and cobas egfr mutation test v2 ROCHE P120019 S030 10/10/2019
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S021 10/10/2019
cobas 4800 braf v600 mutation test Roche Molecular Systems, Inc. P110020 S033 09/25/2019
cobas egfr mutation test v2 ROCHE P120019 S029 09/25/2019
cobas braf v600 muttaion test Roche Molecular Systems, Inc. P110020 S032 05/22/2019
cobas egfr mutation test and cobas egfr mutation test, v2.0 ROCHE P120019 S028 05/22/2019
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S020 05/22/2019
cobas braf v600 mutation test Roche Molecular Systems, Inc. P110020 S031 12/13/2018
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S019 12/13/2018
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