Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease

Genetic Variant Detection And Health Risk Assessment System

Helix OpCo, LLC

The following data is part of a premarket notification filed by Helix Opco, Llc with the FDA for Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease.

Pre-market Notification Details

Device IDK192073
510k NumberK192073
Device Name:Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease
ClassificationGenetic Variant Detection And Health Risk Assessment System
Applicant Helix OpCo, LLC 96 Colbeck Street Toronto,  CA M6s1 V2
ContactGloria Lee
CorrespondentGloria Lee
Helix OpCo, LLC 96 Colbeck Street Toronto,  CA M6s1 V2
Product CodePTA  
CFR Regulation Number866.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-02
Decision Date2020-12-23

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