Device Classification Name |
zinc transporter 8 auto-antibody
|
De Novo Number |
DEN140001 |
Device Name |
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT |
Requester |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
170 s. seneca springs way |
suite 105 |
star,
ID
83669
|
|
Contact |
tanis jimenez |
|
Regulation Number | 866.5670
|
Classification Product Code |
|
Date Received | 06/16/2014 |
Decision Date | 08/20/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Immunology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|