510(k) K861634 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
| Applicant | Wellcome Diagnostics, Research Triangle Pk NC, US |
| Decision | Substantially Equivalent, Oct 29, 1986 |
| Received | Apr 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861634
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.