510(k) K060875 ยท MMI Immunoassay Method, Troponin Subunit
ABBOTT AXSYM TROPONIN-I ADV
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 14, 2006 |
| Received | Mar 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2009 | Abbott Laboratories AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin- Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.