510(k) K905079 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ORTHO RUBELLA-M ANTIBODY ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 4, 1990 |
| Received | Nov 13, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905079
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.