FDA.reportPublic FDA data

De Novo DEN160026

Device
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
Contact
lisa charter
De Novo number
DEN160026
Product code
PTA
Regulation
866.5950
Classification name
genetic variant detection and health risk assessment system
Decision
granted (DENG)
Decision date
2017-04-06
Date received
2016-06-28
Classification advisory
Immunology
Review advisory
Hematology
Type
Direct

Current FDA Classification#

Product code
PTA
Device name
Genetic Variant Detection And Health Risk Assessment System
Medical specialty
Immunology
Device class
2
Regulation
866.5950
Implant
N
Life sustain/support
N