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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 K974167
Device Name WIELISA PR-3 ANCA TEST SYSTEM
Applicant
Wieslab AB
1306 Bailes Ln.
Suite F
Frederick,  MD  21701
Applicant Contact WILLIAM L BOTELER
Correspondent
Wieslab AB
1306 Bailes Ln.
Suite F
Frederick,  MD  21701
Correspondent Contact WILLIAM L BOTELER
Regulation Number866.5660
Classification Product Code
MOB  
Date Received11/05/1997
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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