FDA 510(k) Application Details - K972873

Device Classification Name	Complement C1q, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K972873
Device Name	Complement C1q, Antigen, Antiserum, Control
Applicant	IMMUNOMEDICS, INC. 300 AMERICAN RD. MORRIS PLAINS, NJ 07950 US Other 510(k) Applications for this Company
Contact	JOSEPH E PRESSLITZ 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	08/04/1997
Decision Date	03/17/1998
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