510(k) K170728 ยท KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
E. HISTOLYTICA QUIK CHEK
| Applicant | Techlab, Inc., Blacksburg VA, US |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Mar 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170728
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.