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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Rnp Antibody, Antigen And Control
510(k) Number K071210
Device Name MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
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
LKO  
Subsequent Product Codes
LJM   LKP   LKS   LLL   LSW  
MQA  
Date Received05/01/2007
Decision Date 12/19/2007
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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