Clearance Summary
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 (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) received FDA 510(k) clearance under submission number K260059, sponsored by Hycor Biomedical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2026-05-15.
- Submission: K260059
- Applicant / Sponsor: Hycor Biomedical
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2026-05-15
Classification & Regulation
This clearance is catalogued under FDA product code DHB and 21 CFR 866.5750, within the Immunology review panel as a Class II device.