VIDAS LYME IGG

Reagent, Borrelia Serological Reagent

BIOMERIEUX SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Vidas Lyme Igg.

Pre-market Notification Details

Device IDK122986
510k NumberK122986
Device Name:VIDAS LYME IGG
ClassificationReagent, Borrelia Serological Reagent
Applicant BIOMERIEUX SA CHEMIN DE L ORME Marcy L Etoile,  FR 69280
ContactCatherine Fritsch
CorrespondentCatherine Fritsch
BIOMERIEUX SA CHEMIN DE L ORME Marcy L Etoile,  FR 69280
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-26
Decision Date2013-03-05
Summary:summary

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