ETEST Fosfomycin (FO) (0.032-512 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 Fosfomycin (fo) (0.032-512 µg/ml).

Pre-market Notification Details

Device IDK210757
510k NumberK210757
Device Name:ETEST Fosfomycin (FO) (0.032-512 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 Received2021-03-15
Decision Date2021-11-12

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