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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 K051458
Device Name WIESLAB CAP PR-3 ANCA
Applicant
EURODIAGNOSTICA
1306 BAILES LANE, SUITE F
FREDERICK,  MD  21701
Applicant Contact WILLIAM L BOTELER JR.
Correspondent
EURODIAGNOSTICA
1306 BAILES LANE, SUITE F
FREDERICK,  MD  21701
Correspondent Contact WILLIAM L BOTELER JR.
Regulation Number866.5660
Classification Product Code
MOB  
Date Received06/02/2005
Decision Date 11/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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