FDA 510(k) Application Details - K983895

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K983895
Device Name	System, Test, Beta-2-Microglobulin Immunological
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	RICHARD T ROSS 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	11/03/1998
Decision Date	11/25/1998
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