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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K050286
Device Name FIDIS CONNECTIVE 8
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 Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
LKJ   LKO   LKP   LSW  
Date Received02/07/2005
Decision Date 10/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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