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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 K261027
Device Name NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut
Applicant
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact Aashrey Kaul
Correspondent
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact Aashrey Kaul
Regulation Number866.5750
Classification Product Code
DHB  
Date Received03/30/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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