510(k) K884617 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 2, 1989 |
| Received | Nov 4, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884617
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.