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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 K984228
Device Name IS ANTI-TPO 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 Received11/25/1998
Decision Date 02/02/1999
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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