FDA 510(k) Application Details - K012576

Device Classification Name	Complement C1q, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K012576
Device Name	Complement C1q, Antigen, Antiserum, Control
Applicant	AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 WINDHAM, NH 03087 US Other 510(k) Applications for this Company
Contact	RICHARD E CONLEY 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	08/09/2001
Decision Date	01/29/2002
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