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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name D/Km-1, Antigen, Antiserum, Control
510(k) Number K940243
Device Name VENTANA EMA PRIMARY ANDIBODY
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 Number866.5065
Classification Product Code
DHF  
Date Received01/19/1994
Decision Date 09/07/1994
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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