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Roche

42 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
cobas® EGFR Mutation Test, v2.0 (P120019/S042)Roche2025-12-31
cobas EGFR Mutation Test v2 (P120019/S027)Roche2025-01-27
COBAS EGFR MUTATION TEST (P120019/S040)Roche2024-10-10
Roche cobas EFGR Mutation Test, v2.0 (P120019/S038)Roche2023-12-21
cobas® EGFR Mutation Test, v2.0 (P120019/S037)Roche2023-12-14
cobas® EGFR Mutation Test (P120019/S036)Roche2023-08-23
Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD (P120019/S035)Roche2023-08-17
cobas® EGFR Mutation Test (P120019/S033)Roche2022-11-29
cobas® EGFR Mutation Test, v2.0 (P120019/S034)Roche2022-11-14
cobas EGFR Mutation Test v2 (P120019/S031)Roche2020-10-27
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S032)Roche2020-08-26
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S030)Roche2019-10-10
cobas EGFR Mutation Test v2 (P120019/S029)Roche2019-09-25
COBAS EGFR Mutation Test and cobas EGFR Mutation Test, v2.0 (P120019/S028)Roche2019-05-22
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S026)Roche2018-12-11
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S025)Roche2018-12-07
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S024)Roche2018-09-19
Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit (P120019/S019)Roche2018-08-22
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S023)Roche2018-08-15
cobas EGFR Mutation Test, V2.0 (P120019/S022)Roche2018-07-05
Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit (P120019/S021)Roche2018-07-03
cobas EGFR Mutation Test v2 (P120019/S018)Roche2018-04-18
cobas EGFR Mutation Test v2 (P120019/S016)Roche2018-04-18
Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2 (P120019/S020)Roche2018-03-27
Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test (P120019/S017)Roche2017-11-13
Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit (P120019/S015)Roche2017-10-13
cobas EGFR Mutation Test v2 (P120019/S014)Roche2017-08-15
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S013)Roche2017-08-09
cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2 (P120019/S012)Roche2016-10-19
COBAS EGFR MUTATION TEST (P120019/S011)Roche2016-09-20
COBAS EGFR MUTATION TEST (P120019/S010)Roche2016-08-04
COBAS EGFR MUTATION TEST (P120019/S009)Roche2016-05-13
COBAS EGFR MUTATION TEST V2 (P120019/S007)Roche2015-11-13
ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P120019/S008)Roche2015-07-23
COBAS EGFR MUTATION TEST (P120019/S006)Roche2015-04-09
COBAS EGFR MUTATION TEST (P120019/S005)Roche2015-01-15
COBAS EGFR MUTATION TEST (P120019/S004)Roche2014-03-12
COBAS EGFR MUTATION TEST (P120019/S003)Roche2013-09-12
COBAS EGFR MUTATION TEST (P120019/S002)Roche2013-09-06
COBAS EGFR MUTATION TEST (P120019/S001)Roche2013-08-21
COBAS EGFR MUTATION TEST (P120019)Roche2013-05-14

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Every clearance here is in the API, with alerts when new ones post.