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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 38 Results
PMA Number P120019 Center Devices Decision Date To 01/17/2017
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COBAS EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S028 05/22/2019
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S026 12/11/2018
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S025 12/07/2018
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S024 09/19/2018
Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA S... ROCHE P120019 S019 08/22/2018
cobas EGFR Mutation Test and cobas EGFR Mutation T... ROCHE P120019 S023 08/15/2018
cobas EGFR Mutation Test, V2.0 ROCHE P120019 S022 07/05/2018
Roche cobas EGFR Mutation Test, Roche cobas DNA Sa... ROCHE P120019 S021 07/03/2018
cobas EGFR Mutation Test v2 ROCHE P120019 S018 04/18/2018
cobas EGFR Mutation Test v2 ROCHE P120019 S016 04/18/2018
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