FDA 510(k) Application Details - K173839

Device Classification Name Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

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510(K) Number K173839
Device Name Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Applicant Cancer Genetics, Inc.
1640 Marengo Street
6th Floor
Los Angeles, CA 90033 US
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Contact Janet Graff
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Regulation Number 862.3100

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Classification Product Code OIW
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Date Received 12/18/2017
Decision Date 03/15/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K173839


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