510(k) K955895 ยท KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
E. HISTOLYTICA TEST
| Applicant | Techlab, Inc., Blacksburg VA, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955895
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.