FDA 510(k) Application Details - K012901

Device Classification Name	System, Test, Infectious Mononucleosis   More FDA Info for this Device
510(K) Number	K012901
Device Name	System, Test, Infectious Mononucleosis
Applicant	INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	CAROL MARBLE Other 510(k) Applications for this Contact
Regulation Number	866.5640   More FDA Info for this Regulation Number
Classification Product Code	KTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2001
Decision Date	09/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review