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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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cobas egfr mutation test v2 ROCHE P120019 S031 10/27/2020
cobas braf v600 mutation test Roche Molecular Systems, Inc. P110020 S035 08/26/2020
cobas egfr mutation test and cobas egfr mutation t... ROCHE P120019 S032 08/26/2020
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S023 08/26/2020
cobas® ezh2 mutation test Roche Molecular System, Inc. P200014 S001 08/26/2020
cobas® ezh2 mutation test Roche Molecular System, Inc. P200014 06/18/2020
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S022 05/18/2020
cobas braf v600 mutation test Roche Molecular Systems, Inc. P110020 S034 10/10/2019
cobas egfr mutation test and cobas egfr mutation t... ROCHE P120019 S030 10/10/2019
cobas kras mutation test Roche Molecular Systems, Inc. P140023 S021 10/10/2019
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