This page includes the latest FDA filings for 23andMe, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Manufacturer | Device Name | Date |
|---|
| PMA | Manufacturer | Device Name | Date |
|---|
| De Novo | Manufacturer | Device Name | Date |
|---|---|---|---|
23andMe, Inc. | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 2018-10-31 | |
23andMe, Inc. | 23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants) | 2018-03-06 | |
23andMe | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | 2015-02-19 |
Device GUDID Device Name | Manufacturer | Date |
|---|---|---|
23andMe, Inc. Personal Genome Service®(PGS) | 23ANDME, INC. | 2019-07-05 |
23andMe, Inc. Personal Genome Service®(PGS) | 23ANDME, INC. | 2019-06-27 |
23andMe, Inc. Personal Genome Service® | 23ANDME, INC. | 2018-10-29 |