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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)
Kenota Inc.
335 Gage Ave #1
Kitchener,  CA N2M 5E1
Applicant Contact Martin Mann
Kenota Inc.
335 Gage Ave #1
Kitchener,  CA N2M 5E1
Correspondent Contact Martin Mann
Regulation Number866.5510
Classification Product Code
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