510(k) K260059 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Jan 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260059
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.