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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Assay, Antibody, Progesterone Receptor
510(k) Number K990618
Device Name VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
Applicant
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Applicant Contact JUDITH FREDERICK
Correspondent
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Correspondent Contact JUDITH FREDERICK
Regulation Number864.1860
Classification Product Code
MXZ  
Date Received02/25/1999
Decision Date 07/23/1999
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
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