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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Peroxidase, Antigen, Antiserum, Control
510(k) Number K920600
Device Name DAB DETECTION KIT
Applicant
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Applicant Contact PHILLIP MILLER
Correspondent
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Correspondent Contact PHILLIP MILLER
Regulation Number866.5550
Classification Product Code
DEY  
Date Received02/11/1992
Decision Date 05/11/1992
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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