VITEK 2 AST Gram Negative Cefotaxime (=64 Ug/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 Cefotaxime (=64 Ug/ml).

Pre-market Notification Details

Device IDK161437
510k NumberK161437
Device Name:VITEK 2 AST Gram Negative Cefotaxime (=64 Ug/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM ROAD Hazelwood,  MO  63042
ContactKaren Russell
CorrespondentKaren Russell
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 Received2016-05-24
Decision Date2017-02-16
Summary:summary

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