Clearance Summary
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 received FDA 510(k) clearance under submission number K261027, 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 2026-07-24.
- Submission: K261027
- Applicant / Sponsor: Hycor Biomedical
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5750
- Decision date: 2026-07-24
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.