FDA.reportPublic FDA data

De Novo DEN990008

Device
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
Contact
carroll l martin
De Novo number
DEN990008
Product code
NAK
Regulation
862.1118
Classification name
system, test, biotinidase
Decision
granted (DENG)
Decision date
2000-02-15
Date received
1999-12-20
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Post-NSE

Current FDA Classification#

Product code
NAK
Device name
System, Test, Biotinidase
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1118
Implant
N
Life sustain/support
N