510(k) K954045 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
AXSYM RUBELLA IGG ANTIBODY ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 24, 1996 |
| Received | Aug 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Abbott Laboratories AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20
The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitativ Terminated |
LFX | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an 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.