510(k) K964424 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTAVIRUS EIA
| Applicant | Trinity Biotech, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 8, 1997 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964424
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.