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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 K260280
Device Name NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg
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 Received01/29/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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