FDA 510(k) Application Details - K973203

Device Classification Name	Complement C1q, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K973203
Device Name	Complement C1q, Antigen, Antiserum, Control
Applicant	SANGSTAT MEDICAL CORP. 1505 ADAMS DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	HANA BERGER MORAN 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	08/26/1997
Decision Date	09/30/1998
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