FDA 510(k) Application Details - K972929

Device Classification Name	Albumin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K972929
Device Name	Albumin, Antigen, Antiserum, Control
Applicant	BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	Ruth Forstadt Other 510(k) Applications for this Contact
Regulation Number	866.5040   More FDA Info for this Regulation Number
Classification Product Code	DCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/1997
Decision Date	10/20/1997
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