510(k) K192073
- Device
- Helix Genetic Health Risk App For Late-onset Alzheimer’s Disease
- Applicant
- Helix OpCo, LLC
- 510(k) number
- K192073
- Product code
- PTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-23
- Date received
- 2019-08-02
- Regulation
- 866.5950
- Classification name
- Genetic Variant Detection And Health Risk Assessment System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gloria Lee
- Address
- 96 Colbeck St. Toronto CA M6S1 V2 M6S1 V2
FDA Registration Numbers#
- 3035380687
- 3004597845
- 3003436513
- 3007699459
- 3018077536
- 3015489159
- 3006413195
- 3038181305
Source Documents#
Other 510(k) Records For Product Code PTA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | 2025-01-07 |
| K221420 | AlphaID™ At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | 2020-08-13 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23AndMe, Inc. | 2017-04-06 |
Legacy Summary#
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FDA Review#
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