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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody, Antigen And Control
510(k) Number K060380
Device Name FIDIS DSDNA
Applicant
Biomedical Diagnostics (Bmd) SA
Actipole 25
4-6 Bld De Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Applicant Contact CHRISTELLE COURIVAUD
Correspondent
Biomedical Diagnostics (Bmd) SA
Actipole 25
4-6 Bld De Beaubourg
Marne La Vallee Cedex 2,  FR 77435
Correspondent Contact CHRISTELLE COURIVAUD
Regulation Number866.5100
Classification Product Code
LSW  
Date Received02/14/2006
Decision Date 05/02/2006
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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