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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K231151
Device Name Kenota 1 Total IgE; Kenota 1 (instrument)
Applicant
Kenota, Inc.
335 Gage Ave. #1
Kitchener,  CA N2M 5E1
Applicant Contact Martin Mann
Correspondent
Kenota, Inc.
335 Gage Ave. #1
Kitchener,  CA N2M 5E1
Correspondent Contact Martin Mann
Regulation Number866.5510
Classification Product Code
DGC  
Date Received04/24/2023
Decision Date 05/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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