23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
FDA 510(k) clearance DEN140044 · decided 2015-02-19
Clearance details
- K-number
- DEN140044
- Device name
- 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
- Applicant
- 23AndMe
- Decision
- Unknown
- Date received
- 2014-05-29
- Decision date
- 2015-02-19
- Days to decision
- 266 days
- Clearance type
- Direct
- Product code
- PKB
- Device class
- 2
- Regulation number
- 866.5940
- 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.