23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k) clearance K193492 · decided 2020-08-17
Clearance details
- K-number
- K193492
- Device name
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant
- 23AndMe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-17
- Decision date
- 2020-08-17
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- QDJ
- Device class
- 2
- Regulation number
- 862.3364
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Sunnyvale, 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) Pharmacogenetic Reports (K221885) | 23AndMe, Inc. | 2022-10-26 |
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (DEN180028) | 23AndMe, Inc. | 2018-10-31 |
Recalls involving this device
No recalls on record reference this clearance.