The following data is part of a De Novo classification by 23andme, Inc. with the FDA for 23andme Personal Genome Service (pgs) Genetic Health Risk Test For Hereditary Thrombophilia.
| DeNovo ID | DEN160026 |
| Device Name: | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia |
| Classification | Genetic Variant Detection And Health Risk Assessment System |
| Applicant | 23andMe, Inc. 899 West Evelyn Avenue Mountain View, CA 94041 |
| Contact | Lisa Charter |
| Product Code | PTA |
| CFR Regulation Number | 866.5950 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Hematology |
| Classification Advisory | Immunology |
| Type | Direct |
| Date Received | 2016-06-28 |
| Decision Date | 2017-04-06 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |