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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 K193393
Device Name BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
Applicant
Leica Biosystems Newcastle, Ltd.
Balliol Business Park W.
Benton Lane
Newcastle Upon Tyne,  GB NE12 8EW
Applicant Contact Matthew West
Correspondent
Leica Biosystems
38 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Zhijun (Julie) Pan
Regulation Number864.1860
Classification Product Code
MXZ  
Date Received12/06/2019
Decision Date 03/06/2020
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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