510(k) K261027 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Mar 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261027
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.