FDA 510(k) Application Details - K002731

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K002731
Device Name	System, Test, Beta-2-Microglobulin Immunological
Applicant	DADE BEHRING, INC. 7739 NW 48 ST. SUITE 120 MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	RADAMES RIESGO 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	09/01/2000
Decision Date	11/20/2000
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