FDA 510(k) Application Details - K053571

Device Classification Name	System, Analysis, Electrophoretic Hemoglobin   More FDA Info for this Device
510(K) Number	K053571
Device Name	System, Analysis, Electrophoretic Hemoglobin
Applicant	INTERLAB S.R.L. 150 CHERRY LANE ROAD EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	864.7440   More FDA Info for this Regulation Number
Classification Product Code	JBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2005
Decision Date	06/30/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review