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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lynch Syndrome Test System
510(k) Number K213348
Device Name BOND MMR Antibody Panel
Applicant
Leica Biosystems Newcastle, Ltd.
Balliol Business Park W.
Benton Lane
Newcastle Upon Tyne,  GB NE12 8EW
Applicant Contact Kristin Godfredsen
Correspondent
Leica Biosystems Newcastle, Ltd.
Balliol Business Park W.
Benton Lane
Newcastle Upon Tyne,  GB NE12 8EW
Correspondent Contact Christine Kishi
Regulation Number864.1866
Classification Product Code
PZJ  
Date Received10/08/2021
Decision Date 02/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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