This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Relocation of manufacturing activities related to production of critical components.
| Device | cobas KRAS Mutation Test |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2017-07-14 |
| Decision Date | 2017-08-09 |
| PMA | P140023 |
| Supplement | S009 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140023 | Original Filing | |
| S025 | 2022-10-21 | 30-day Notice |
| S024 | ||
| S023 | 2020-07-27 | 30-day Notice |
| S022 | 2020-02-18 | Real-time Process |
| S021 | 2019-09-20 | 30-day Notice |
| S020 | 2019-04-24 | 30-day Notice |
| S019 | 2018-11-13 | 30-day Notice |
| S018 | 2018-11-09 | 30-day Notice |
| S017 | 2018-08-21 | 30-day Notice |
| S016 | 2018-07-27 | 30-day Notice |
| S015 | 2018-06-08 | 30-day Notice |
| S014 | 2018-06-04 | 30-day Notice |
| S013 | 2018-03-01 | 30-day Notice |
| S012 | 2017-10-30 | 30-day Notice |
| S011 | 2017-09-27 | 30-day Notice |
| S010 | 2017-07-17 | 30-day Notice |
| S009 | 2017-07-14 | 30-day Notice |
| S008 | 2016-09-22 | 30-day Notice |
| S007 | 2016-08-22 | 30-day Notice |
| S006 | 2016-07-08 | 30-day Notice |
| S005 | 2016-04-18 | 30-day Notice |
| S004 | 2016-02-29 | Normal 180 Day Track |
| S003 | 2016-01-28 | Real-time Process |
| S002 | 2015-09-02 | 30-day Notice |
| S001 | 2015-06-24 | 30-day Notice |