Device Classification Name |
direct-to-consumer access pharmacogenetic assessment system
|
De Novo Number |
DEN180028 |
Device Name |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
Requester |
23andme, inc. |
899 w. evelyn ave., |
mountain view,
CA
94041
|
|
Contact |
adam odeh |
|
Regulation Number | 862.3364
|
Classification Product Code |
|
Date Received | 06/05/2018 |
Decision Date | 10/31/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Molecular Genetics
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|