FDA 510(k) Application Details - K080896

Device Classification Name	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types   More FDA Info for this Device
510(K) Number	K080896
Device Name	Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Applicant	PATHWORK DIAGNOSTICS, INC. 1196 BORREGAS AVE. SUITE 200 SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati 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	03/31/2008
Decision Date	07/30/2008
Decision	SESU - SE - WITH LIMITATIONS
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