510(k) K974103 ยท MMI Immunoassay Method, Troponin Subunit
ABBOTT AXSYM TROPONIN-I
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 25, 1997 |
| Received | Oct 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.