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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 K103818
Device Name CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
VENTANA MEDICAL SYTEMS, INC
1910 E. INNOVATIONS PARK DRIVE
TUCSON,  AZ  85755
Applicant Contact GEORGE DE LA ROSA
Correspondent
VENTANA MEDICAL SYTEMS, INC
1910 E. INNOVATIONS PARK DRIVE
TUCSON,  AZ  85755
Correspondent Contact GEORGE DE LA ROSA
Regulation Number864.1860
Classification Product Code
MXZ  
Date Received12/29/2010
Decision Date 11/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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