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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 K130861
Device Name MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
Applicant
Dako North America, Inc.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact JENNIFER M CHAMBERS
Correspondent
Dako North America, Inc.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact JENNIFER M CHAMBERS
Regulation Number864.1860
Classification Product Code
MXZ  
Date Received03/28/2013
Decision Date 12/09/2013
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
Predetermined Change
Control Plan Authorized		 No
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