510(k) K841319 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTALEX LATEX AGGLUTINATION TEST
| Applicant | Orion Diagnostica, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 14, 1984 |
| Received | Apr 2, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841319
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.