FDA.reportPublic FDA data

De Novo DEN200001

Device
Cell-Free DNA BCT
Contact
deborah kipp
De Novo number
DEN200001
Product code
QMA
Regulation
862.1676
Classification name
blood collection device for cell-free nucleic acid
Decision
granted (DENG)
Decision date
2020-08-07
Date received
2020-01-10
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
QMA
Device name
Blood Collection Device For Cell-Free Nucleic Acid
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1676
Implant
N
Life sustain/support
N