FDA 510(k) Application Details - K061602

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K061602
Device Name	Device, Automated Cell-Locating
Applicant	BIOVIEW LTD. 7 JABOTINSKY ST. RAMAT GAN 52520 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	06/08/2006
Decision Date	01/23/2007
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