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 supplier of bovine serum albumin (bsa) for use inthe manufacture of precursor components for the architect hbsag qualitative (ln 4p53),architect hbsag qualitative confirmatory (ln 4p54), and architect afp (ln 3p36) assays.
| Device | ARCHITECT AFP ASSAY (LN 3P36) |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | Abbott Laboratories |
| Date Received | 2015-06-15 |
| Decision Date | 2015-07-13 |
| PMA | P120008 |
| Supplement | S008 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 09v6 Ap5-2n 100 Abbott Park Road abbott Park, IL 60064 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120008 | Original Filing | |
| S021 | 2023-01-06 | 30-day Notice |
| S020 | 2022-09-14 | 30-day Notice |
| S019 | 2021-11-18 | 30-day Notice |
| S018 | 2021-11-09 | 30-day Notice |
| S017 | 2021-02-09 | Real-time Process |
| S016 | 2020-10-16 | 30-day Notice |
| S015 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S014 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | 2018-11-13 | 30-day Notice |
| S011 | ||
| S010 | 2016-10-04 | 30-day Notice |
| S009 | 2015-07-16 | 30-day Notice |
| S008 | 2015-06-15 | 30-day Notice |
| S007 | 2014-11-13 | 30-day Notice |
| S006 | 2014-03-18 | 30-day Notice |
| S005 | 2013-10-30 | 30-day Notice |
| S004 | 2013-10-28 | 30-day Notice |
| S003 | 2013-05-13 | 30-day Notice |
| S002 | 2013-02-19 | Normal 180 Day Track |
| S001 | 2013-02-11 | 30-day Notice |