Device Classification Name |
cancer predisposition risk assessment system
|
De Novo Number |
DEN170046 |
Device Name |
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
Requester |
23andme, inc. |
899 w.evelyn ave |
mountain view,
CA
94041
|
|
Contact |
lisa charter |
|
Regulation Number | 866.6090
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 03/06/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Molecular Genetics
|
Review Advisory Committee |
Pathology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|