510(k) K954318 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 14, 1996 |
| Received | Sep 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2007 | Abbott Laboratories AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.