FDA 510(k) Application Details - K992440

Device Classification Name	System, Test, Anticardiolipin Immunological   More FDA Info for this Device
510(K) Number	K992440
Device Name	System, Test, Anticardiolipin Immunological
Applicant	COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK MIDLOTHIAN, SCOTLAND EH26 OPL GB Other 510(k) Applications for this Company
Contact	DANIELLE M KNIGHT 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	07/22/1999
Decision Date	09/21/1999
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