FDA 510(k) Application Details - K984188

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K984188
Device Name	Device, Automated Cell-Locating
Applicant	CHROMAVISION MEDICAL SYSTEMS, INC. 3535 FIREWHEEL DR. SUITE A FLOWER MOUND, TX 75028-2628 US Other 510(k) Applications for this Company
Contact	BERTRAM J HUDSON Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/1998
Decision Date	07/28/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review