FDA 510(k) Application Details - K964767

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K964767
Device Name	System, Test, Beta-2-Microglobulin Immunological
Applicant	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS 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	11/27/1996
Decision Date	05/29/1997
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