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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 K992791
Device Name BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
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 Received08/19/1999
Decision Date 11/12/1999
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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