Helix Genetic Health Risk App for late-onset Alzheimers disease— 510(k) K192073
Substantially EquivalentHelix Opco, LLC
FDA 510(k) clearance K192073 for Helix Genetic Health Risk App for late-onset Alzheimers disease, Substantially Equivalent on 2020-12-23. Applicant: Helix Opco, LLC.
Clearance details
- Applicant
- Helix Opco, LLC
- Product code
- Code PTA
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.