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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K944505
Device Name DIASTAT ENA SINGLE WELL SCREEN KIT
Applicant
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Applicant Contact PETER FOSTER
Correspondent
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Correspondent Contact PETER FOSTER
Regulation Number866.5100
Classification Product Code
LLL  
Date Received09/14/1994
Decision Date 11/21/1994
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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