Device Classification Name |
meprobamate test system
|
De Novo Number |
DEN170010 |
Device Name |
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay |
Requester |
lin-zhi international, inc. |
2945 oakmead village court |
santa clara,
CA
95051
|
|
Contact |
chris wang |
|
Regulation Number | 862.3590
|
Classification Product Code |
|
Date Received | 02/21/2017 |
Decision Date | 04/20/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Toxicology
|
Review Advisory Committee |
Toxicology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|