FDA 510(k) Application Details - K080254

Device Classification Name	Automated Digital Image Manual Interpretation Microscope   More FDA Info for this Device
510(K) Number	K080254
Device Name	Automated Digital Image Manual Interpretation Microscope
Applicant	APERIO TECHNOLOGIES 1430 VANTAGE COURT VISTA, CA 92081 US Other 510(k) Applications for this Company
Contact	JEFF RYBERG Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	OEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2008
Decision Date	10/31/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review