510(k) K942286 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
DIARLEX ROTA-ADENO
| Applicant | Orion Diagnostica, Inc., 02101 Espoo, FI |
| Decision | Substantially Equivalent, Dec 14, 1994 |
| Received | Apr 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942286
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.