The following data is part of a De Novo classification by 23andme with the FDA for 23andme Personal Genome Service (hereinafter Known As Pgs).
| DeNovo ID | DEN140044 |
| Device Name: | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) |
| Classification | Autosomal Recessive Carrier Screening Gene Mutation Detection System |
| Applicant | 23andMe 1390 Shorebird Way Mountain View, CA 94043 |
| Contact | Kathy Hibbs |
| Product Code | PKB |
| CFR Regulation Number | 866.5940 [🔎] |
| 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 | Immunology |
| Type | Direct |
| Date Received | 2014-05-29 |
| Decision Date | 2015-02-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859462006095 | DEN140044 | 000 |
| 00859462006279 | DEN140044 | 000 |
| 00859462006262 | DEN140044 | 000 |
| 00859462006378 | DEN140044 | 000 |
| 00859462006385 | DEN140044 | 000 |
| 00859462006392 | DEN140044 | 000 |
| 00859462006408 | DEN140044 | 000 |
| 00859462006415 | DEN140044 | 000 |