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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Antibody Assay, Estrogen Receptor
510(k) Number K984567
Device Name VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
Applicant
Ventana, Inc.
3865 N. Business Center
Drive
Tucson,  AZ  85705
Applicant Contact JUDITH FREDERICK
Correspondent
Ventana, Inc.
3865 N. Business Center
Drive
Tucson,  AZ  85705
Correspondent Contact JUDITH FREDERICK
Regulation Number864.1860
Classification Product Code
MYA  
Date Received12/23/1998
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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