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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
Model NCL-ER 6F11 BOND
Device Name VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Original Applicant
LEICA BIOSYSTEMS NEWCASTLE LTD
5205 route 12
richmond,  IL  60071
Original Contact barbara-ann conway-mayers
Regulation Number864.1860
Classification Product Code
MYA  
Date Received08/29/2012
Decision Date 05/19/2014
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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