FDA 510(k) Application Details - K030238

Device Classification Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K030238
Device Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD SANTA MONICA, CA 90404 US Other 510(k) Applications for this Company
Contact	JAY H GELLER Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	DBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2003
Decision Date	03/24/2003
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