510(k) K885295 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 23, 1989 |
| Received | Dec 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885295
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.