FDA 510(k) Application Details - K141109

Device Classification Name	Microscope, Automated, Image Analysis, Operator Intervention   More FDA Info for this Device
510(K) Number	K141109
Device Name	Microscope, Automated, Image Analysis, Operator Intervention
Applicant	LEICA BIOSYSTEMS IMAGING, INC. 1360 PARK CENTER DRIVE VISTA, CA 92081 US Other 510(k) Applications for this Company
Contact	CHRISTINE KISHI Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NOT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2014
Decision Date	07/29/2014
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