FDA 510(k) Application Details - K071652

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K071652
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	HEMOCUE AB 40 EMPIRE DRIVE LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	ALLAN WHITE Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	GKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2007
Decision Date	10/25/2007
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