The following data is part of a De Novo classification by 23andme, Inc. with the FDA for 23andme Pgs Genetic Health Risk Report For Brca1/brca2 (selected Variants).
| DeNovo ID | DEN170046 |
| Device Name: | 23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants) |
| Classification | Cancer Predisposition Risk Assessment System |
| Applicant | 23andMe, Inc. 899 W.evelyn Ave Mountain View, CA 94041 |
| Contact | Lisa Charter |
| Product Code | QAZ |
| CFR Regulation Number | 866.6090 [🔎] |
| 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 | Pathology |
| Classification Advisory | Molecular Genetics |
| Type | Direct |
| Date Received | 2017-09-05 |
| Decision Date | 2018-03-06 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |