FDA 510(k) Application Details - K013263

Device Classification Name	Anti-Sm Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K013263
Device Name	Anti-Sm Antibody, Antigen And Control
Applicant	FRED HUTCHINSON CANCER RESEARCH CENTER 7914 VIA CALLENDO CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	SHELBY J HALL Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2001
Decision Date	07/29/2002
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