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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name next generation sequencing based tumor profiling test
De Novo Number DEN170058
Device Name MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
Memorial Sloan-Kettering Cancer Center
department of pathology
444 e 68th street h505
new york,  NY  10065
Contact christine england
Regulation Number866.6080
Classification Product Code
Date Received09/25/2017
Decision Date 11/15/2017
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct