510(k) DEN180028
- Device
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant
- 23AndMe, Inc.
- 510(k) number
- DEN180028
- Product code
- QDJ
- Decision
- Unknown (DENG)
- Decision date
- 2018-10-31
- Date received
- 2018-06-05
- Regulation
- 862.3364
- Classification name
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- Medical specialty
- Medical Genetics
- Review panel
- Medical Genetics
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Adam Odeh
- Address
- 899 W. Evelyn Ave. Mountain View CA US 94041 94041
FDA Registration Numbers#
- 3007699459
Source Documents#
510(k) summary PDF not indicated by FDA