510(k) DEN140044
- Device
- 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
- Applicant
- 23AndMe
- 510(k) number
- DEN140044
- Product code
- PKB
- Decision
- Unknown (DENG)
- Decision date
- 2015-02-19
- Date received
- 2014-05-29
- Regulation
- 866.5940
- Classification name
- Autosomal Recessive Carrier Screening Gene Mutation Detection System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kathy Hibbs
- Address
- 1390 Shorebird Way Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3007699459
Source Documents#
510(k) summary PDF not indicated by FDA