Device Classification Name |
aquaporin-4 autoantibody
|
De Novo Number |
DEN150030 |
Device Name |
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay |
Requester |
kronus, inc. |
170 s. seneca springs way, suite 105 |
star,
ID
83669
|
|
Contact |
brian deis |
|
Regulation Number | 866.5665
|
Classification Product Code |
|
Date Received | 07/02/2015 |
Decision Date | 04/25/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Immunology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|