ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

Manual Antimicrobial Susceptibility Test Systems

BioMérieux S.A.

The following data is part of a premarket notification filed by Biomérieux S.a. with the FDA for Etest Plazomicin (plz) (0.016-256 µg/ml).

Pre-market Notification Details

Device IDK200512
510k NumberK200512
Device Name:ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant bioMérieux S.A. 376 Chemin De L'Orme Marcy L'etoile,  FR 69280
ContactAlexia Bosquet
CorrespondentAlexia Bosquet
bioMérieux S.A. 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 Received2020-03-02
Decision Date2020-05-07

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