FDA 510(k) Application Details - K042939

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K042939
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	Sebia, Inc. 13805 WATERLOO CHELSEA, MI 48118 US Other 510(k) Applications for this Company
Contact	BOREK JANIK Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2004
Decision Date	06/27/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review