Helix Genetic Health Risk App for late-onset Alzheimers disease— 510(k) K192073

Name: FDA 510(k) clearance K192073
Creator: U.S. Food and Drug Administration
Published: 2020-12-23

Substantially Equivalent

Helix Opco, LLC

FDA 510(k) clearance K192073 for Helix Genetic Health Risk App for late-onset Alzheimers disease, Substantially Equivalent on 2020-12-23. Applicant: Helix Opco, LLC. Device class: 2.

Clearance details

Applicant: Helix Opco, LLC
Product code: Code PTA
Device class: Class 2
Regulation: 21 CFR 866.5950
Advisory panel: Immunology
Date received: 2019-08-02
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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