FDA.reportPublic FDA data

De Novo DEN180028

Device
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Contact
adam odeh
De Novo number
DEN180028
Product code
QDJ
Regulation
862.3364
Classification name
direct-to-consumer access pharmacogenetic assessment system
Decision
granted (DENG)
Decision date
2018-10-31
Date received
2018-06-05
Classification advisory
Molecular Genetics
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
QDJ
Device name
Direct-To-Consumer Access Pharmacogenetic Assessment System
Medical specialty
Medical Genetics
Device class
2
Regulation
862.3364
Implant
N
Life sustain/support
N