510(k) K896479 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 29, 1989 |
| Received | Nov 13, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896479
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.