FDA 510(k) Application Details - K040591

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K040591
Device Name	Device, Automated Cell-Locating
Applicant	BIOVIEW LTD. 12 HAMADA ST. REHOVOT 76703 IL Other 510(k) Applications for this Company
Contact	DORIT WINITZ 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	03/08/2004
Decision Date	09/16/2004
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