FDA.reportPublic FDA data

De Novo DEN040011

Device
AMPLICHIP CYP450 TEST, MODEL 04381866190
Contact
james f kelly
De Novo number
DEN040011
Product code
NTI
Regulation
862.3360
Classification name
drug metabolizing enzyme genotyping systems
Decision
granted (DENG)
Decision date
2004-12-23
Date received
2004-12-20
Classification advisory
Toxicology
Review advisory
Clinical Chemistry
Type
Post-NSE

Current FDA Classification#

Product code
NTI
Device name
Drug Metabolizing Enzyme Genotyping Systems
Medical specialty
Clinical Toxicology
Device class
2
Regulation
862.3360
Implant
N
Life sustain/support
N