FDA 510(k) Application Details - K965033

Device Classification Name	Alpha-1 Microglobulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K965033
Device Name	Alpha-1 Microglobulin, Antigen, Antiserum, Control
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 BREA, CA 92622-8000 US Other 510(k) Applications for this Company
Contact	ANNETTE HELLIE Other 510(k) Applications for this Contact
Regulation Number	866.5400   More FDA Info for this Regulation Number
Classification Product Code	MGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/1996
Decision Date	04/21/1997
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