FDA 510(k) Application Details - K061047

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K061047
Device Name	System, Hemoglobin, Automated
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	864.5620   More FDA Info for this Regulation Number
Classification Product Code	GKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2006
Decision Date	06/08/2006
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