Cleared Traditional

K252775 - NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) (FDA 510(k) Clearance)

Also includes:
Capture Reagent F076, Bos d 4 a-lactalbumin, Milk Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk Capture Reagent F232, Gal d 2 Ovalbumin, Egg
K252775 · Hycor Biomedical · Immunology device
Jan 2026
Decision
136d
Days
Class 2
Risk

K252775 is an FDA 510(k) clearance for the NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea). This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K252775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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