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FDA 510(k) Application Details - K173839
Device Classification Name
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Janet Graff
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
OIW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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