23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) — 23AndMe, Inc. (510(k) K211499)
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) — 23AndMe, Inc. (510(k) K211499) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related); Applicant: 23AndMe, Inc.; Clearance t
| Device name | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) |
|---|---|
| Applicant | 23AndMe, Inc. |
| Clearance track | 510(k) |
| Submission number | K211499 |
| Decision | Substantially Equivalent |
| Decision date | 2022-01-06 |
| Date received | 2021-05-14 |
| Product code | QAZ |
| Device class | 2 |
| Medical specialty | Medical Genetics |
| Applicant location | CA, US |
| Source | openFDA device |
🔍 Search all device clearances →
$1999/mo
Try DeviceClear →