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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 K070458
Device Name MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
Applicant
Biomedical Diagnostics (Bmd) SA
Actipole 25
4-6 Bld De Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Applicant Contact COURIVAUD CHRISTELLE
Correspondent
Biomedical Diagnostics (Bmd) SA
Actipole 25
4-6 Bld De Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Correspondent Contact COURIVAUD CHRISTELLE
Regulation Number866.5660
Classification Product Code
MOB  
Subsequent Product Code
MVJ  
Date Received02/16/2007
Decision Date 12/21/2007
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
Predetermined Change
Control Plan Authorized		 No
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