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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 K191635
Device Name Optilite IgM Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Applicant Contact Natasha Verhaak
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Correspondent Contact Natasha Verhaak
Regulation Number866.5510
Classification Product Code
CFN  
Date Received06/19/2019
Decision Date 07/15/2019
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
Recalls CDRH Recalls
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