FDA 510(k) Application Details - K983655

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K983655
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/1998
Decision Date	01/28/1999
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