FDA 510(k) Application Details - K032113

Device Classification Name	Microscope, Automated, Image Analysis, Operator Intervention   More FDA Info for this Device
510(K) Number	K032113
Device Name	Microscope, Automated, Image Analysis, Operator Intervention
Applicant	CHROMA VISION MEDICAL SYSTEMS INC. 33171 PASEO CERVEZA SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	DAVID DAVIS 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	07/09/2003
Decision Date	12/23/2003
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