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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, c-reactive protein
510(k) Number K172868
Device Name Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
Applicant
The Binding Site Group Ltd.
8 Calthorpe Road, Edgbaston
Birmingham,  GB B15 1QT
Applicant Contact Kirsty Samuels
Correspondent
The Binding Site Group Ltd.
8 Calthorpe Road, Edgbaston
Birmingham,  GB B15 1QT
Correspondent Contact Kirsty Samuels
Regulation Number866.5270
Classification Product Code
DCN  
Date Received09/20/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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