FDA 510(k) Application Details - K002215

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K002215
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	COGENT DIAGNOTICS LTD. BUSH LOAN PENICUIK MIDLOTHIAN EH26 0PL 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	MOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2000
Decision Date	09/28/2000
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