23AndMe, Inc.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories2
Latest FDA decision2023-08-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | 2023-08-31 | View |
| 510(k) | K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | 2022-10-26 | View |
| 510(k) | K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | QAZ | 2022-01-06 | View |
| 510(k) | K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | 2020-08-17 | View |
| 510(k) | K182784 | MUTYH-Associated Polyposis (MAP) | QAZ | 2019-01-18 | View |
No matching devices.