The following data is part of a De Novo classification by 23andme, Inc. with the FDA for 23andme Personal Genome Service (pgs) Pharmacogenetic Reports.
| DeNovo ID | DEN180028 |
| Device Name: | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
| Classification | Direct-to-consumer Access Pharmacogenetic Assessment System |
| Applicant | 23andMe, Inc. 899 W. Evelyn Ave., Mountain View, CA 94041 |
| Contact | Adam Odeh |
| Product Code | QDJ |
| CFR Regulation Number | 862.3364 [🔎] |
| 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 | Clinical Chemistry |
| Classification Advisory | Molecular Genetics |
| Type | Direct |
| Date Received | 2018-06-05 |
| Decision Date | 2018-10-31 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |