FDA.reportPublic FDA data

De Novo DEN040012

Device
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
Contact
robert lipshutz
De Novo number
DEN040012
Product code
NSU
Regulation
862.2570
Classification name
instrumentation for clinical multiplex test systems
Decision
granted (DENG)
Decision date
2004-12-23
Date received
2004-11-03
Classification advisory
Clinical Chemistry
Review advisory
Toxicology
Type
Post-NSE

Current FDA Classification#

Product code
NSU
Device name
Instrumentation For Clinical Multiplex Test Systems
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.2570
Implant
N
Life sustain/support
N