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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 K983553
Device Name ANTI-TG IGG ELISA TEST SYSTEM
Applicant
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Applicant Contact NORMAN JENKINS
Correspondent
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Correspondent Contact NORMAN JENKINS
Regulation Number866.5870
Classification Product Code
JZO  
Date Received10/09/1998
Decision Date 12/07/1998
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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