510(k) K853448 ยท KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
HILLCREST AMEBIASIS IHA TEST
| Applicant | Hillcrest Biologicals, Cypress CA, US |
| Decision | Substantially Equivalent, Aug 28, 1985 |
| Received | Aug 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853448
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.