23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia is an AI-enabled medical device from 23andMe, Inc., listed by FDA (De Novo, DEN160026) with a decision date of 2017-04-06. Review panel: Immunology.
| FDA submission number | DEN160026 |
|---|---|
| Pathway | De Novo |
| Company | 23andMe, Inc. |
| Review panel (specialty) | Immunology |
| FDA decision date | 2017-04-06 |
| Decision | Unknown |
| Product code | PTA |
| Classification | Genetic Variant Detection And Health Risk Assessment System |
| Device class | 2 |
| Regulation number | 866.5950 |
| Review time (calendar days) | 282 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.