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.
Removal of incoming acceptance testing for two raw materials.
| Device | COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2015-06-24 |
| Decision Date | 2015-07-23 |
| PMA | P100020 |
| Supplement | S015 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| 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 |
|---|---|---|
| P100020 | Original Filing | |
| S054 | 2022-10-21 | 30-day Notice |
| S053 | 2020-07-27 | 30-day Notice |
| S052 | 2020-06-01 | 30-day Notice |
| S051 | 2020-04-17 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | ||
| S048 | 2019-08-08 | 30-day Notice |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-04-08 | 30-day Notice |
| S044 | 2019-04-03 | 30-day Notice |
| S043 | 2019-02-04 | 30-day Notice |
| S042 | 2018-12-14 | 30-day Notice |
| S041 | 2018-11-13 | 30-day Notice |
| S040 | 2018-11-09 | 30-day Notice |
| S039 | 2018-10-25 | 30-day Notice |
| S038 | 2018-08-21 | 30-day Notice |
| S037 | 2018-07-27 | 30-day Notice |
| S036 | 2018-06-29 | 30-day Notice |
| S035 | 2018-06-08 | 30-day Notice |
| S034 | 2018-06-04 | 30-day Notice |
| S033 | 2018-05-23 | 30-day Notice |
| S032 | 2018-05-09 | Real-time Process |
| S031 | 2018-05-04 | 30-day Notice |
| S030 | 2018-04-16 | 30-day Notice |
| S029 | 2018-03-01 | 30-day Notice |
| S028 | 2017-12-07 | 30-day Notice |
| S027 | 2017-10-30 | 30-day Notice |
| S026 | 2017-09-26 | 30-day Notice |
| S025 | 2017-07-28 | Normal 180 Day Track |
| S024 | 2017-07-17 | 30-day Notice |
| S023 | 2017-07-14 | 30-day Notice |
| S022 | 2017-07-14 | 30-day Notice |
| S021 | 2016-09-22 | 30-day Notice |
| S020 | 2016-07-08 | 30-day Notice |
| S019 | 2016-04-18 | 30-day Notice |
| S018 | 2016-04-07 | 30-day Notice |
| S017 | 2015-12-23 | Panel Track |
| S016 | ||
| S015 | 2015-06-24 | 30-day Notice |
| S014 | 2015-03-13 | 30-day Notice |
| S013 | 2015-02-25 | Real-time Process |
| S012 | 2013-11-05 | Real-time Process |
| S011 | 2013-08-14 | 30-day Notice |
| S010 | 2013-08-09 | 30-day Notice |
| S009 | 2013-07-26 | 30-day Notice |
| S008 | 2013-07-01 | Panel Track |
| S007 | 2012-10-09 | 30-day Notice |
| S006 | 2012-08-15 | 30-day Notice |
| S005 | 2012-07-02 | Real-time Process |
| S004 | 2012-04-02 | Normal 180 Day Track |
| S003 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S002 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S001 | 2011-05-31 | Normal 180 Day Track No User Fee |