FDA.reportPublic FDA data

De Novo DEN170058

Device
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
Contact
christine england
De Novo number
DEN170058
Product code
PZM
Regulation
866.6080
Classification name
next generation sequencing based tumor profiling test
Decision
granted (DENG)
Decision date
2017-11-15
Date received
2017-09-25
Classification advisory
Pathology
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
PZM
Device name
Next Generation Sequencing Based Tumor Profiling Test
Medical specialty
Pathology
Device class
2
Regulation
866.6080
Implant
N
Life sustain/support
N