510(k) K854129 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
| Applicant | Orion Diagnostica, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Jan 21, 1986 |
| Received | Oct 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854129
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.