Helix Genetic Health Risk App for late-onset Alzheimers disease
K-Number: K192073 · 2020-12-23
ApplicantHelix Opco, LLC
Decision Date2020-12-23
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Helix Genetic Health Risk App for late-onset Alzheimers disease is a medical device manufactured by Helix Opco, LLC. It received FDA 510(k) clearance on 2020-12-23 under approval 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 Alzheimers disease?
Helix Genetic Health Risk App for late-onset Alzheimers disease is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Helix Opco, LLC. The 510(k) number is K192073.
When was Helix Genetic Health Risk App for late-onset Alzheimers disease approved by the FDA?
Helix Genetic Health Risk App for late-onset Alzheimers disease received FDA 510(k) clearance on 2020-12-23, under approval number K192073.
What company makes Helix Genetic Health Risk App for late-onset Alzheimers disease?
Helix Genetic Health Risk App for late-onset Alzheimers disease is manufactured by Helix Opco, LLC.
What is the FDA product code for Helix Genetic Health Risk App for late-onset Alzheimers disease?
The FDA product code for Helix Genetic Health Risk App for late-onset Alzheimers disease is PTA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.