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.
Manufacturing process change to increase the concentration of the intermediate storage form (isf) bulk component common to all devices.
| Device | ELECSYS ANTI-HBC-IGM ON COBAS E 411 |
| 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 | 2012-02-02 |
| Decision Date | 2012-02-27 |
| PMA | P110031 |
| Supplement | S003 |
| Product Code | LOM |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |
|---|---|---|
| P110031 | Original Filing | |
| S024 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S023 | 2018-10-09 | 30-day Notice |
| S022 | 2018-03-01 | Real-time Process |
| S021 | ||
| S020 | 2017-10-11 | Real-time Process |
| S019 | 2017-08-03 | 30-day Notice |
| S018 | 2017-05-24 | 30-day Notice |
| S017 | 2016-12-07 | Real-time Process |
| S016 | 2016-09-07 | Normal 180 Day Track No User Fee |
| S015 | 2016-07-11 | 135 Review Track For 30-day Notice |
| S014 | 2016-02-16 | 30-day Notice |
| S013 | 2016-01-27 | 30-day Notice |
| S012 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S011 | 2015-10-07 | 30-day Notice |
| S010 | 2013-07-19 | Special (immediate Track) |
| S009 | ||
| S008 | 2012-11-30 | 30-day Notice |
| S007 | ||
| S006 | 2012-02-29 | 30-day Notice |
| S005 | 2012-02-02 | 30-day Notice |
| S004 | 2012-02-02 | 30-day Notice |
| S003 | 2012-02-02 | 30-day Notice |
| S002 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S001 | 2012-01-31 | Normal 180 Day Track No User Fee |