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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 K940583
Device Name VENTANA CD45 PRIMARY ANTIBODY
Applicant
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Applicant Contact KURT REINHARDT
Correspondent
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Correspondent Contact KURT REINHARDT
Regulation Number866.5550
Classification Product Code
DEH  
Date Received02/08/1994
Decision Date 10/20/1997
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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