510(k) K895805 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
SLIDEX ROTA-KIT 2
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Feb 26, 1991 |
| Received | Sep 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895805
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.