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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K942813
Device Name DIASTAT ANTI-PR3 (C-ANCA) KIT
Applicant
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Applicant Contact GEORGE ZAJICEK
Correspondent
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Correspondent Contact GEORGE ZAJICEK
Regulation Number866.5660
Classification Product Code
MOB  
Date Received06/14/1994
Decision Date 03/06/1995
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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