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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K935161
Device Name KERATIN PRIMARY ANTIBODY
Applicant
VENTANA MEDICAL SYSTEMS, INC.
3865 NORTH BUSINESS CENTER DR.
TUCSON,  AZ  85705
Applicant Contact STEPHEN TILLSON
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
3865 NORTH BUSINESS CENTER DR.
TUCSON,  AZ  85705
Correspondent Contact STEPHEN TILLSON
Regulation Number866.5550
Classification Product Code
DEH  
Date Received10/29/1993
Decision Date 03/22/1996
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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