FDA.reportPublic FDA data

De Novo DEN070009

Device
MAMMAPRINT
Contact
guildo brink
De Novo number
DEN070009
Product code
NYI
Regulation
866.6040
Classification name
classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Decision
granted (DENG)
Decision date
2007-02-06
Date received
2007-01-30
Classification advisory
Immunology
Review advisory
Pathology
Type
Post-NSE

Current FDA Classification#

Product code
NYI
Device name
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Medical specialty
Immunology
Device class
2
Regulation
866.6040
Implant
N
Life sustain/support
N