23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
FDA 510(k) clearance DEN160026 · decided 2017-04-06
Clearance details
- K-number
- DEN160026
- Device name
- 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
- Applicant
- 23AndMe, Inc.
- Decision
- Unknown
- Date received
- 2016-06-28
- Decision date
- 2017-04-06
- Days to decision
- 282 days
- Clearance type
- Direct
- Product code
- PTA
- Device class
- 2
- Regulation number
- 866.5950
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.