FDA 510(k) Application Details - K042241

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K042241
Device Name	Ige, Antigen, Antiserum, Control
Applicant	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US Other 510(k) Applications for this Company
Contact	BRIAN SCHLIESMAN Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2004
Decision Date	12/10/2004
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