510(k) K900604 ยท KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
| Applicant | Biovir Laboratories, Inc., Benicia CA, US |
| Decision | Substantially Equivalent, Jul 26, 1990 |
| Received | Feb 8, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900604
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.