510(k) K252493

NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) by Hycor Biomedical — Product Code DHB

K252493 is an FDA 510(k) premarket notification submitted by Hycor Biomedical for the device "NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code DHB (System, Test, Radioallergosorbent (Rast) Immunological), a Class II device regulated under 21 CFR 866.5750. Hycor Biomedical has at least 10 other 510(k) clearances on record.