510(k) K041811 ยท MMI Immunoassay Method, Troponin Subunit
ABBOTT AXSYM TROPONIN-I ADV
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 10, 2004 |
| Received | Jul 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2007 | Abbott Laboratories AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | None listed |
| Nov 17, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.