510(k) DEN160026
- Device
- 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
- Applicant
- 23AndMe, Inc.
- 510(k) number
- DEN160026
- Product code
- PTA
- Decision
- Unknown (DENG)
- Decision date
- 2017-04-06
- Date received
- 2016-06-28
- Regulation
- 866.5950
- Classification name
- Genetic Variant Detection And Health Risk Assessment System
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lisa Charter
- Address
- 899 W. Evelyn Ave. Mountain View CA US 94041 94041
FDA Registration Numbers#
- 3035380687
- 3004597845
- 3003436513
- 3007699459
- 3018077536
- 3015489159
- 3006413195
- 3038181305
Source Documents#
510(k) summary PDF not indicated by FDA
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