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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name software, similarity score algorithm, tissue of origin for malignant tumor types
510(k) Number K173839
Device Name Tissue of Origin Test Kit-FFPE
Cancer Genetics, Inc.
1640 Marengo Street
6th Floor
Los Angeles,  CA  90033
Applicant Contact Janet Graff
Cancer Genetics, Inc.
133 Southcenter Court
Morrisville,  NC  27560
Correspondent Contact Victoria Kusel
Regulation Number862.3100
Classification Product Code
Date Received12/18/2017
Decision Date 03/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No