510(k) K931059 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
IMX RUBELLA IGM ANTIBODY ASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 19, 1994 |
| Received | Mar 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931059
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; 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.