FDA 510(k) Application Details - K983921

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K983921
Device Name	Extractable Antinuclear Antibody, Antigen And Control
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	LLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1998
Decision Date	12/28/1998
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