23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k) clearance DEN170046 · decided 2018-03-06
Clearance details
- K-number
- DEN170046
- Device name
- 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- Applicant
- 23AndMe, Inc.
- Decision
- Unknown
- Date received
- 2017-09-05
- Decision date
- 2018-03-06
- Days to decision
- 182 days
- Clearance type
- Direct
- Product code
- QAZ
- Device class
- 2
- Regulation number
- 866.6090
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (K223597) | 23AndMe, Inc. | 2023-08-31 |
| 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (K211499) | 23AndMe, Inc. | 2022-01-06 |
| MUTYH-Associated Polyposis (MAP) (K182784) | 23AndMe, Inc. | 2019-01-18 |
Recalls involving this device
No recalls on record reference this clearance.