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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 K932386
Device Name VENTANA RED DETECTION KIT
Applicant
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Applicant Contact STEPHEN A TILLLSON
Correspondent
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Correspondent Contact STEPHEN A TILLLSON
Regulation Number866.5550
Classification Product Code
DEY  
Date Received05/17/1993
Decision Date 08/09/1993
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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