510(k) K954575 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
AXSYM TOXO IGG ANTIBODY ASSAY
| Applicant | Abbott Laboratories, Buffalo NY, US |
| Decision | Substantially Equivalent, Aug 16, 1996 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2007 | Abbott Laboratories AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LGD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.