VITEK 2 AST-Gram Negative Imipenem/Relebactam (=16/4 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 Imipenem/relebactam (=16/4 µg/ml).

Pre-market Notification Details

Device IDK193572
510k NumberK193572
Device Name:VITEK 2 AST-Gram Negative Imipenem/Relebactam (=16/4 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
ContactJolyn Tenllado
CorrespondentJolyn Tenllado
BioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
Product CodeLON  
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-03-13

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