23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k) clearance DEN180028 · decided 2018-10-31
Clearance details
- K-number
- DEN180028
- Device name
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant
- 23AndMe, Inc.
- Decision
- Unknown
- Date received
- 2018-06-05
- Decision date
- 2018-10-31
- Days to decision
- 148 days
- Clearance type
- Direct
- Product code
- QDJ
- Device class
- 2
- Regulation number
- 862.3364
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch 23AndMe
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K193492) | 23AndMe, Inc. | 2020-08-17 |
Recalls involving this device
No recalls on record reference this clearance.