FDA 510(k) Application Details - K963286

Device Classification Name	Haptoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K963286
Device Name	Haptoglobin, 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	MARGIE GEORGE Other 510(k) Applications for this Contact
Regulation Number	866.5460   More FDA Info for this Regulation Number
Classification Product Code	DAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1996
Decision Date	10/07/1996
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