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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K963525
Device Name DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
Applicant
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Applicant Contact EILEEN MCCAFFERTY
Correspondent
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.5660
Classification Product Code
DBL  
Date Received09/04/1996
Decision Date 11/07/1996
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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