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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 K122556
Device Name VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Applicant
LEICA BIOSYSTEMS NEWCASTLE LTD
5205 Route 12
Richmond,  IL  60071
Applicant Contact BARBARA-ANN CONWAY-MAYERS
Correspondent
LEICA BIOSYSTEMS NEWCASTLE LTD
5205 Route 12
Richmond,  IL  60071
Correspondent Contact BARBARA-ANN CONWAY-MAYERS
Regulation Number864.1860
Classification Product Code
MYA  
Date Received08/22/2012
Decision Date 05/19/2014
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
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