FDA 510(k) Application Details - K011244

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K011244
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	ZEUS SCIENTIFIC, INC. P.O. BOX 38 RARITAN, NJ 08869 US Other 510(k) Applications for this Company
Contact	MARK J KOPNITSKY Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2001
Decision Date	12/10/2001
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