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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K260591
Device Name NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
Applicant
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact Hiromi Kubota
Correspondent
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact Hiromi Kubota
Regulation Number866.5750
Classification Product Code
DHB  
Date Received02/23/2026
Decision Date 07/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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