FDA 510(k) Application Details - DEN170058

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170058
Device Name	MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
Applicant	Memorial Sloan-Kettering Cancer Center Department of Pathology 444 E 68th Street H505 New York, NY 10065 US Other 510(k) Applications for this Company
Contact	Christine England Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2017
Decision Date	11/15/2017
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review