The following data is part of a premarket notification filed by Helix Opco, Llc with the FDA for Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease.
| Device ID | K192073 |
| 510k Number | K192073 |
| Device Name: | Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease |
| Classification | Genetic Variant Detection And Health Risk Assessment System |
| Applicant | Helix OpCo, LLC 96 Colbeck Street Toronto, CA M6s1 V2 |
| Contact | Gloria Lee |
| Correspondent | Gloria Lee Helix OpCo, LLC 96 Colbeck Street Toronto, CA M6s1 V2 |
| Product Code | PTA |
| CFR Regulation Number | 866.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2020-12-23 |