Cleared Traditional

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ?-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

K252775 · Hycor Biomedical · Immunology
Jan 2026
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K252775 is an FDA 510(k) clearance for the NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ?-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on January 16, 2026, 136 days after receiving the submission on September 2, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K252775 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2025
Decision Date January 16, 2026
Days to Decision 136 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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