FDA Product Code
FDA Product Code PTA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5950
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | 2025-01-07 | Traditional | PDF ↗ |
| K221420 | AlphaID At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 | Traditional | PDF ↗ |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | Helix Opco, LLC | 2020-12-23 | Traditional | PDF ↗ |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | 2020-08-13 | Traditional | PDF ↗ |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23AndMe, Inc. | 2017-04-06 | Direct | — |
Product code PTA · Class II · Immunology. Data: openFDA.