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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K153560
Device Name Optilite Low Level Albumin Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston
Birmingham,  GB B15 1qt
Applicant Contact JON LAUDER
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston
Birmingham,  GB B15 1qt
Correspondent Contact JON LAUDER
Regulation Number866.5040
Classification Product Code
DCF  
Date Received12/14/2015
Decision Date 08/25/2016
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
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