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 to modify the architect i1000sr probe wash with an alternate wash delivery system (awds), and to modify the architect i2000sr and alinity i with induction heating (ih)
| Device | ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | Abbott Laboratories |
| Date Received | 2021-02-09 |
| Decision Date | 2021-04-22 |
| PMA | P120008 |
| Supplement | S017 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |