FDA 510(k) Application Details - K982622

Device Classification Name	Extractable Antinuclear Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K982622
Device Name	Extractable Antinuclear Antibody, Antigen And Control
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	866.5100   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	06/18/1998
Decision Date	08/13/1998
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