VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (=64/8 µg/mL)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BioMerieux, Inc

The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vitek 2 Ast-gram Negative Meropenem/vaborbactam (=64/8 µg/ml).

Pre-market Notification Details

Device IDK183360
510k NumberK183360
Device Name:VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (=64/8 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc 595 Anglum Road Hazlewood,  MO  63042
ContactEsther Hernandez
CorrespondentEsther Hernandez
bioMerieux, Inc 595 Anglum Road Hazlewood,  MO  63042
Product CodeLON  
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-04
Decision Date2019-02-26
Summary:summary

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