FDA 510(k)

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

K-Number: K192073 · 2020-12-23

Decision Date2020-12-23

Product CodePTA

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Helix Genetic Health Risk App for late-onset Alzheimer’s disease is the device name listed in this FDA 510(k) record. The listed applicant is Helix Opco, LLC. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K192073. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

Helix Genetic Health Risk App for late-onset Alzheimer’s disease is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Helix Opco, LLC. The 510(k) number is K192073.

When did Helix Genetic Health Risk App for late-onset Alzheimer’s disease receive FDA 510(k) clearance?

Helix Genetic Health Risk App for late-onset Alzheimer’s disease received FDA 510(k) clearance on 2020-12-23, under 510(k) number K192073.

Who is the listed applicant for Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

The FDA 510(k) record lists Helix Opco, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helix Genetic Health Risk App for late-onset Alzheimer’s disease?

The FDA product code for Helix Genetic Health Risk App for late-onset Alzheimer’s disease is PTA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.