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.
Change to the manufacturing process and quality control test method for the hbcag solutio nand the change to the manufacturing process for the qualified rhbcag used in the axsym core 2. 0 assay.
| Device | AXSYM CORE 2.0 |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ABBOTT LABORATORIES INC |
| Date Received | 2010-09-21 |
| Decision Date | 2010-10-20 |
| PMA | P060012 |
| Supplement | S003 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT LABORATORIES INC 100 Abbott Park Road ap5n-2, Dept. 09vb abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060012 | Original Filing | |
| S010 | 2012-11-13 | 30-day Notice |
| S009 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S008 | 2011-09-07 | Special (immediate Track) |
| S007 | 2011-03-21 | 135 Review Track For 30-day Notice |
| S006 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S005 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S004 | 2010-09-27 | 30-day Notice |
| S003 | 2010-09-21 | 30-day Notice |
| S002 | 2010-05-19 | 30-day Notice |
| S001 | 2007-01-17 | 30-day Notice |