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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K173732
Device Name Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston
Birmingham,  GB B15 1qt
Applicant Contact Christopher Bradshaw
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston
Birmingham,  GB B15 1qt
Correspondent Contact Andrea Thomas
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received12/06/2017
Decision Date 08/23/2018
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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