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.
| Device | ARCHITECT CORE-M / Alinity i Anti-HBc IgM |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-14 |
| Decision Date | 2022-10-12 |
| PMA | P060035 |
| Supplement | S035 |
| 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 100 Abbott Park Rd. ap5n-2, Dept. 09vb abbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add An Additional Supplier For A Kit Component |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060035 | Original Filing | |
| S037 | 2023-01-06 | 30-day Notice |
| S036 | 2022-09-27 | 30-day Notice |
| S035 | 2022-09-14 | 30-day Notice |
| S034 | 2021-11-18 | 30-day Notice |
| S033 | 2021-11-09 | 30-day Notice |
| S032 | 2021-02-09 | Real-time Process |
| S031 | ||
| S030 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S029 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S028 | ||
| S027 | 2018-10-22 | 30-day Notice |
| S026 | 2018-06-01 | Normal 180 Day Track |
| S025 | 2015-07-16 | 30-day Notice |
| S024 | 2014-11-13 | 30-day Notice |
| S023 | 2014-09-19 | 30-day Notice |
| S022 | 2013-10-30 | 30-day Notice |
| S021 | 2013-10-28 | 30-day Notice |
| S020 | 2013-02-15 | 30-day Notice |
| S019 | 2013-02-11 | 30-day Notice |
| S018 | 2012-11-19 | 30-day Notice |
| S017 | 2012-11-15 | 30-day Notice |
| S016 | 2012-11-13 | 30-day Notice |
| S015 | 2012-11-01 | 30-day Notice |
| S014 | 2012-08-03 | 30-day Notice |
| S013 | 2011-11-23 | Special (immediate Track) |
| S012 | 2011-10-28 | 30-day Notice |
| S011 | 2011-10-28 | 135 Review Track For 30-day Notice |
| S010 | 2011-09-07 | Special (immediate Track) |
| S009 | 2011-05-25 | 30-day Notice |
| S008 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S007 | 2011-04-18 | 30-day Notice |
| S006 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S005 | 2011-01-10 | 135 Review Track For 30-day Notice |
| S004 | 2010-12-22 | Special (immediate Track) |
| S003 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S002 | 2010-08-02 | Normal 180 Day Track No User Fee |
| S001 | 2009-01-08 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00380740011154 | P060035 | 001 |
| 00380740011147 | P060035 | 001 |
| 00380740011130 | P060035 | 001 |
| 00380740146177 | P060035 | 026 |
| 00380740145187 | P060035 | 026 |
| 00380740130282 | P060035 | 026 |