FDA 510(k) Application Details - K032254

Device Classification Name	Complement C1q, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K032254
Device Name	Complement C1q, Antigen, Antiserum, Control
Applicant	IBL GMBH 150 CHERRY LANE RD. EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	DAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2003
Decision Date	08/29/2003
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