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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K973392
Device Name CHEMMATE LAMBDA
Applicant
VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON,  AZ  85705
Applicant Contact KATHLEEN WINDALL
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON,  AZ  85705
Correspondent Contact KATHLEEN WINDALL
Regulation Number866.5130
Classification Product Code
DEM  
Date Received07/09/1997
Decision Date 10/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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