FDA 510(k) Application Details - K955449

Device Classification Name	System, Test, Anticardiolipin Immunological   More FDA Info for this Device
510(K) Number	K955449
Device Name	System, Test, Anticardiolipin Immunological
Applicant	AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 WINDHAM, NH 03087 US Other 510(k) Applications for this Company
Contact	RICHARD CONLEY Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/1995
Decision Date	05/23/1996
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