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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 K020349
Device Name ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Place
Dundee, Scotland,  GB DD2 1XA
Applicant Contact EILEEN A MCCAFFERTY
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Luna Place
Dundee, Scotland,  GB DD2 1XA
Correspondent Contact EILEEN A MCCAFFERTY
Regulation Number866.5870
Classification Product Code
JZO  
Date Received02/04/2002
Decision Date 05/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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