FDA.reportPublic FDA data

De Novo DEN170010

Device
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
Contact
chris wang
De Novo number
DEN170010
Product code
QBK
Regulation
862.3590
Classification name
meprobamate test system
Decision
granted (DENG)
Decision date
2018-04-20
Date received
2017-02-21
Classification advisory
Toxicology
Review advisory
Toxicology
Type
Direct

Current FDA Classification#

Product code
QBK
Device name
Meprobamate Test System
Medical specialty
Clinical Toxicology
Device class
2
Regulation
862.3590
Implant
N
Life sustain/support
N