510(k) K260280 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg
| Applicant | Hycor Biomedical, Garden Grove CA, US |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Jan 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260280
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.