K252775

Substantially Equivalent

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 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Applicant: Hycor Biomedical
Product code: DHB
Advisory panel: Immunology
Date received: 2025-09-02
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

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