510(k) K953943 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
AXSYM CMV IGG ANTIBODY ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 20, 1996 |
| Received | Aug 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953943
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2009 | Abbott Laboratories AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to Terminated |
LFZ | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.