510(k) K983759 ยท DBF Ferritin, Antigen, Antiserum, Control
ABBOTT ARCHITECT FERRITIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 7, 1998 |
| Received | Oct 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Ferritin Reagent Kit, List Number 07P6530
The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human s Terminated |
DBF | None listed |
| Jul 4, 2006 | Abbott Laboratories MPG ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
DBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.