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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 SA
chemin de l orme
marcy l etoile, 
Contact catherine fritsch
Regulation Number866.3830
Classification Product Code
LSR  
Date Received09/26/2012
Decision Date 03/05/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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