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510(k) K193492

Device
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant
23AndMe, Inc.
510(k) number
K193492
Product code
QDJ
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-17
Date received
2019-12-17
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lisa Charter
Address
223 N Mathilda Ave. Sunnyvale CA US 94086 94086

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QDJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K22188523andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc.2022-10-26
DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc.2018-10-31