510(k) K894544 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
BIOTROL RUB-E.I.A. TEST G
| Applicant | Biotrol, USA, Inc., Westchester PA, US |
| Decision | Substantially Equivalent, Aug 30, 1989 |
| Received | Jul 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894544
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.