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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, nephelometric, immunoglobulins (g, a, m)
510(k) Number K192116
Device Name Human IgA liquid reagent kit for Use on SPAPlus
Applicant
The Binding Site Group Ltd
8 Calthorpe Road Edgbaston
Birmingham,  GB B15 1QT
Applicant Contact Natasha Verhaak
Correspondent
The Binding Site Group Ltd
8 Calthorpe Road Edgbaston
Birmingham,  GB B15 1QT
Correspondent Contact Natasha Verhaak
Regulation Number866.5510
Classification Product Code
CFN  
Date Received08/06/2019
Decision Date 09/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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