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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 K952183
Device Name DIASTAT ANTI-THYROGLOBULIN KIT
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Applicant Contact EILEEN A MCCAFFERTY
Correspondent
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE,  GB DD2 1SW
Correspondent Contact EILEEN A MCCAFFERTY
Regulation Number866.5870
Classification Product Code
JZO  
Date Received05/09/1995
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
Recalls CDRH Recalls
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