FDA 510(k) Application Details - K974564

Device Classification Name	Alpha-2-Macroglobulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K974564
Device Name	Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-104 BREA, CA 92621 US Other 510(k) Applications for this Company
Contact	ANNETTE HELLIE Other 510(k) Applications for this Contact
Regulation Number	866.5620   More FDA Info for this Regulation Number
Classification Product Code	DEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1997
Decision Date	02/17/1998
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