Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - DEN170046
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170046
Device Name
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant
23andMe, Inc.
899 W.Evelyn Ave
Mountain View, CA 94041 US
Other 510(k) Applications for this Company
Contact
Lisa Charter
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2017
Decision Date
03/06/2018
Decision
DENG -
Classification Advisory Committee
MG -
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact