FDA.reportPublic FDA data

De Novo DEN040008

Device
CEDIA SIROLIMUS ASSAY
Contact
david casal
De Novo number
DEN040008
Product code
NRP
Regulation
862.3840
Classification name
sirolimus test system
Decision
granted (DENG)
Decision date
2004-07-28
Date received
2004-06-17
Classification advisory
Toxicology
Review advisory
Clinical Chemistry
Type
Post-NSE

Current FDA Classification#

Product code
NRP
Device name
Sirolimus Test System
Medical specialty
Clinical Toxicology
Device class
2
Regulation
862.3840
Implant
N
Life sustain/support
N