Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Requester
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
PZM  
Date Received09/25/2017
Decision Date 11/15/2017
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-