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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 K220162
Device Name Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Applicant
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact Irene M. Guzman
Correspondent
Hycor Biomedical
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact Irene M. Guzman
Regulation Number866.5750
Classification Product Code
DHB  
Date Received01/20/2022
Decision Date 02/18/2022
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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