FDA.reportPublic FDA data

De Novo DEN190028

Device
MyCare Psychiatry Clozapine Assay Kit
Contact
sue werner
De Novo number
DEN190028
Product code
QKT
Regulation
862.3245
Classification name
clozapine test system
Decision
granted (DENG)
Decision date
2020-04-16
Date received
2019-05-24
Classification advisory
Clinical Chemistry
Review advisory
Toxicology
Type
Direct

Current FDA Classification#

Product code
QKT
Device name
Clozapine Test System
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.3245
Implant
N
Life sustain/support
N