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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 K000286
Device Name BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
Applicant
Brahms Diagnostica, LLC
29 S. Peachtree St.
Norcross,  GA  30071
Applicant Contact H. LEE HERRON
Correspondent
Brahms Diagnostica, LLC
29 S. Peachtree St.
Norcross,  GA  30071
Correspondent Contact H. LEE HERRON
Regulation Number866.5870
Classification Product Code
JZO  
Date Received01/31/2000
Decision Date 03/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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