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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 Rd.
Edgbaston
Birmingham,  GB B15 1qt
Applicant Contact Natasha Verhaak
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
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
Predetermined Change
Control Plan Authorized		 No
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