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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name genetic variant detection and health risk assessment system
510(k) Number K192073
Device Name Helix Genetic Health Risk App for late-onset Alzheimer’s disease
Helix OpCo, LLC
96 Colbeck Street
toronto,  CA m6s1 v2
Applicant Contact gloria lee
Helix OpCo, LLC
96 Colbeck Street
toronto,  CA m6s1 v2
Correspondent Contact gloria lee
Regulation Number866.5950
Classification Product Code
Date Received08/02/2019
Decision Date 12/23/2020
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