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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 K951487
Device Name DIASTAT ANTI-THYROID PEROXIDASE KIT
Applicant
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Applicant Contact PEER FOSTER
Correspondent
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Correspondent Contact PEER FOSTER
Regulation Number866.5870
Classification Product Code
JZO  
Date Received03/31/1995
Decision Date 06/30/1995
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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