510(k) K861172 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
ROTAVIRUS LATEX AGGLUTINATION ASSAY
| Applicant | Bartels Immunodiagnostic Supplies, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Jul 1, 1986 |
| Received | Mar 28, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861172
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.