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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 K940331
Device Name KERATIN PRIMARY ANTIBODY
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 Number866.5550
Classification Product Code
DEH  
Date Received01/24/1994
Decision Date 02/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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