FDA 510(k) Application Details - K072078

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K072078
Device Name	System, Test, Beta-2-Microglobulin Immunological
Applicant	BIOKIT S.A. CAN MALE S/N LLICA D'AMUNT BARCELONA 08186 ES Other 510(k) Applications for this Company
Contact	JOAN GUIXER Other 510(k) Applications for this Contact
Regulation Number	866.5630   More FDA Info for this Regulation Number
Classification Product Code	JZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2007
Decision Date	12/19/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review