VITEK 2 AST-Gram Negative Meropenem (=16 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 (=16 µg/ml).

Pre-market Notification Details

Device IDK201675
510k NumberK201675
Device Name:VITEK 2 AST-Gram Negative Meropenem (=16 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
ContactDebra Broyles
CorrespondentDebra Broyles
bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
Product CodeLON  
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2021-07-09

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