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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K122986
Device Name VIDAS LYME IGG
Applicant
Biomerieux S.A.
Chemin De L Orme
Marcy L Etoile,  FR 69280
Applicant Contact CATHERINE FRITSCH
Correspondent
Biomerieux S.A.
Chemin De L Orme
Marcy L Etoile,  FR 69280
Correspondent Contact CATHERINE FRITSCH
Regulation Number866.3830
Classification Product Code
LSR  
Date Received09/26/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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