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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 K102607
Device Name FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
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
LJM   LKJ   LKO   LKP   LSW  
MQA   NSU  
Date Received09/10/2010
Decision Date 12/03/2010
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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