510(k) K911444 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
| Applicant | Wampole Laboratories, Cranbury NJ, US |
| Decision | Substantially Equivalent, Aug 30, 1991 |
| Received | Apr 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911444
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.