MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay— 510(k) DEN170058

Name: FDA 510(k) clearance DEN170058
Creator: U.S. Food and Drug Administration
Published: 2017-11-15

Unknown

Memorial Sloan-Kettering Cancer Center

FDA 510(k) clearance DEN170058 for MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay, Unknown on 2017-11-15. Applicant: Memorial Sloan-Kettering Cancer Center. Device class: 2.

Clearance details

Applicant: Memorial Sloan-Kettering Cancer Center
Product code: Code PZM
Device class: Class 2
Regulation: 21 CFR 866.6080
Advisory panel: Pathology
Date received: 2017-09-25
Decision date: 2017-11-15
Decision: Unknown
Clearance type: Direct
Location: New York, NY, US

View on FDA.gov ↗

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