FDA.reportPublic FDA data

De Novo DEN040010

Device
VYSIS AUTOVYSION SYSTEM
Contact
lynda hague
De Novo number
DEN040010
Product code
NTH
Regulation
866.4700
Classification name
system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
Decision
granted (DENG)
Decision date
2004-12-13
Date received
2004-10-13
Classification advisory
Immunology
Review advisory
Pathology
Type
Post-NSE

Current FDA Classification#

Product code
NTH
Device name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Medical specialty
Immunology
Device class
2
Regulation
866.4700
Implant
N
Life sustain/support
N