Source document or public record
FDA 510(k) K192073 — Helix Genetic Health Risk App for late-onset Alzheimers disease
FDA 510(k) index record K192073. Device: Helix Genetic Health Risk App for late-onset Alzheimers disease. Applicant as listed: Helix Opco, LLC. Decision date: 2020-12-23.
Source
"device_name": "Helix Genetic Health Risk App for late-onset Alzheimers disease"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K192073.
Device name: Helix Genetic Health Risk App for late-onset Alzheimers disease. Applicant as listed: Helix Opco, LLC.
Decision date: 2020-12-23. Decision wording: Substantially Equivalent.
Product code: PTA. Regulation: 21 CFR 866.5950. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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