510(k) K080766 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
VIDAS RUB IGG
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 23, 2008 |
| Received | Mar 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080766
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.