FDA.reportPublic FDA data

De Novo DEN050007

Device
HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
Contact
linda d bentley
De Novo number
DEN050007
Product code
NRK
Regulation
874.1600
Classification name
kit, test, olfactory
Decision
granted (DENG)
Decision date
2006-03-27
Date received
2005-06-20
Classification advisory
Ear Nose & Throat
Review advisory
Ear Nose & Throat
Type
Post-NSE

Current FDA Classification#

Product code
NRK
Device name
Kit, Test, Olfactory
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation
874.1600
Implant
N
Life sustain/support
N