510(k) K831133 ยท KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
AMEBIASIS BIO-ENZABEAD SCREEN KIT
| Applicant | Bionetic Laboratory Products, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 8, 1983 |
| Received | Apr 7, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831133
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.