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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 K252493
Device Name 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)
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 Received08/08/2025
Decision Date 12/23/2025
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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