FDA.reportPublic FDA data

De Novo DEN030005

Device
FACTOR V LEIDEN KIT
Contact
robert a gregg
De Novo number
DEN030005
Product code
NPQ
Regulation
864.7280
Classification name
test, factor v leiden mutations, genomic dna pcr
Decision
granted (DENG)
Decision date
2003-12-17
Date received
2003-12-08
Classification advisory
Hematology
Review advisory
Pathology
Type
Post-NSE

Current FDA Classification#

Product code
NPQ
Device name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Medical specialty
Hematology
Device class
2
Regulation
864.7280
Implant
N
Life sustain/support
N