FDA 510(k) Application Details - K092967

Device Classification Name	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types   More FDA Info for this Device
510(K) Number	K092967
Device Name	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Applicant	PATHWORK DIAGNOSTICS 595 PENOBSCOT DRIVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	ANNA LONGWELL 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	09/25/2009
Decision Date	06/08/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review