ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

Manual Antimicrobial Susceptibility Test Systems

BioMerieux SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Meropenem/vaborbactam (mev) (0.004/8-64/8 µg/ml).

Pre-market Notification Details

Device IDK183031
510k NumberK183031
Device Name:ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile,  FR 69280
ContactMarine Taravant
CorrespondentMarine Taravant
bioMerieux SA 376 Chemin De L'Orme Marcy L'etoile,  FR 69280
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-01
Decision Date2019-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026623739 K183031 000

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