Name: Predicase
Price: 199 USD

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
Product code	PZM
Device class	Class II
Decision date	Nov 15, 2017
Decision	Not Substantially Equivalent
Regulation	866.6080

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Source

View the full FDA submission: accessdata.fda.gov

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MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

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