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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 K120663
Device Name MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria,  CA  93013
Applicant Contact xiaolei xu
Correspondent
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria,  CA  93013
Correspondent Contact xiaolei xu
Regulation Number864.1860
Classification Product Code
MYA  
Date Received03/05/2012
Decision Date 02/12/2013
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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