ETEST Eravacycline (ERV) (0.002 – 32 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 Eravacycline (erv) (0.002 – 32 µg/ml).

Pre-market Notification Details

Device IDK192050
510k NumberK192050
Device Name:ETEST Eravacycline (ERV) (0.002 – 32 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 Received2019-07-31
Decision Date2019-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026560997 K192050 000

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