FDA.reportPublic FDA data

De Novo DEN140044

Device
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
Contact
kathy hibbs
De Novo number
DEN140044
Product code
PKB
Regulation
866.5940
Classification name
autosomal recessive carrier screening gene mutation detection system
Decision
granted (DENG)
Decision date
2015-02-19
Date received
2014-05-29
Classification advisory
Immunology
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
PKB
Device name
Autosomal Recessive Carrier Screening Gene Mutation Detection System
Medical specialty
Immunology
Device class
2
Regulation
866.5940
Implant
N
Life sustain/support
N