FDA 510(k) Application Details - K973882

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K973882
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant	THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. CHICAGO, IL 60612-3501 US Other 510(k) Applications for this Company
Contact	MARIUS TEODORESCU Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MSV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/1997
Decision Date	12/05/1997
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