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 the extension of the elecsys hbsag immunoassay and elecsys hbsag confirmatory test onto the cobas e 602 immunoassay analyzer.
| Device | ELECSYS HBSAG (HBSAG) TEST SYSTEM |
| 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 | 2011-10-11 |
| Decision Date | 2012-03-19 |
| PMA | P990012 |
| Supplement | S012 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |