Cleared Traditional

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)

K252493 · Hycor Biomedical · Immunology
Dec 2025
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K252493 is an FDA 510(k) clearance for the 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), 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 December 23, 2025, 137 days after receiving the submission on August 8, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K252493 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2025
Decision Date December 23, 2025
Days to Decision 137 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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