Device Classification Name |
whole exome sequencing constituent device
|
De Novo Number |
DEN190035 |
Device Name |
Helix Laboratory Platform |
Requester |
Helix OpCo, LLC |
96 colbeck street |
toronto,
CA
m6s1 v2
|
|
Contact |
gloria lee |
|
Regulation Number | 866.6000
|
Classification Product Code |
|
Date Received | 08/02/2019 |
Decision Date | 12/23/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Molecular Genetics
|
Review Advisory Committee |
Molecular Genetics
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|