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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, Thyroid Autoantibody
510(k) Number K033454
Device Name BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
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 Number866.5870
Classification Product Code
JZO  
Date Received10/30/2003
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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