510(k) K864811 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTA-STAT
| Applicant | Intl. Diagnostic Laboratories, Ltd., Israel, IL |
| Decision | Substantially Equivalent, Aug 25, 1987 |
| Received | Dec 9, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864811
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.