FDA 510(k) Application Details - K940583

Device Classification Name	Lambda, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K940583
Device Name	Lambda, Antigen, Antiserum, Control
Applicant	VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. TUCSON, AZ 85705 US Other 510(k) Applications for this Company
Contact	KURT REINHARDT Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/1994
Decision Date	10/20/1997
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