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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Thyroglobulin
510(k) Number K021057
Device Name BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
Applicant
Brahms Diagnostica, LLC
35 B S. Peachtree St.
Norcross,  GA  30071
Applicant Contact WILLIAM G FRANK
Correspondent
Brahms Diagnostica, LLC
35 B S. Peachtree St.
Norcross,  GA  30071
Correspondent Contact WILLIAM G FRANK
Regulation Number866.6010
Classification Product Code
MSW  
Date Received04/01/2002
Decision Date 09/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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