FDA 510(k) Application Details - K973389

Device Classification Name	Alpha-1-Antitrypsin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K973389
Device Name	Alpha-1-Antitrypsin, 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	KATHLEEN WINDALL Other 510(k) Applications for this Contact
Regulation Number	866.5130   More FDA Info for this Regulation Number
Classification Product Code	DEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/1997
Decision Date	10/03/1997
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