K-number	K192073
Device name	Helix Genetic Health Risk App for late-onset Alzheimers disease
Applicant	Helix Opco, LLC
Product code	PTA
Device class	Class II
Decision date	Dec 23, 2020
Decision	Substantially Equivalent
Regulation	866.5950

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Source

View the full FDA submission: accessdata.fda.gov

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Helix Genetic Health Risk App for late-onset Alzheimers disease

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Helix Genetic Health Risk App for late-onset Alzheimers disease