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.
Approval for a software update (version 06-05) for the cobas 8000 modular analyzer series
| Device | Elecsys HBsAg Immunoassay |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2018-04-17 |
| Decision Date | 2018-06-13 |
| PMA | P990012 |
| Supplement | S032 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0457 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990012 | Original Filing | |
| S033 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S032 | 2018-04-17 | Real-time Process |
| S031 | 2018-03-01 | Real-time Process |
| S030 | ||
| S029 | 2017-10-11 | Real-time Process |
| S028 | 2017-08-03 | 30-day Notice |
| S027 | 2016-10-26 | 30-day Notice |
| S026 | 2016-02-16 | 30-day Notice |
| S025 | 2016-01-27 | 30-day Notice |
| S024 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S023 | 2015-10-07 | 30-day Notice |
| S022 | 2014-11-25 | 30-day Notice |
| S021 | 2014-04-04 | Real-time Process |
| S020 | 2013-04-09 | Real-time Process |
| S019 | 2012-11-30 | 30-day Notice |
| S018 | 2012-10-04 | 30-day Notice |
| S017 | 2012-10-04 | 30-day Notice |
| S016 | 2012-10-03 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2012-02-29 | 30-day Notice |
| S013 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S012 | 2011-10-11 | Normal 180 Day Track |
| S011 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S010 | 2011-08-17 | 135 Review Track For 30-day Notice |
| S009 | 2011-05-17 | Normal 180 Day Track No User Fee |
| S008 | 2011-04-11 | 30-day Notice |
| S007 | 2008-09-02 | 30-day Notice |
| S006 | 2008-04-30 | Normal 180 Day Track |
| S005 | 2007-09-04 | Normal 180 Day Track |
| S004 | ||
| S003 | 2005-10-14 | Special (immediate Track) |
| S002 | 2005-08-02 | 135 Review Track For 30-day Notice |
| S001 | 2004-09-29 | Normal 180 Day Track |