510(k) K260591 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Jul 21, 2026 |
| Received | Feb 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260591
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.