510(k) K862431 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELLA IGM EIA TEST KIT
| Applicant | Labsystems, Inc., Morton Grove IL, US |
| Decision | Substantially Equivalent, Aug 8, 1986 |
| Received | Jun 26, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862431
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.