510(k) K860529 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTALEX
| Applicant | Orion Corp., 20101 Turku, FI |
| Decision | Substantially Equivalent, Mar 4, 1986 |
| Received | Feb 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860529
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.