VITEK 2 AST-GN Gentamicin (=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-gn Gentamicin (=16 µg/ml).

Pre-market Notification Details

Device IDK163563
510k NumberK163563
Device Name:VITEK 2 AST-GN Gentamicin (=16 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
ContactCherece L. Jones
CorrespondentCherece L. Jones
bioMerieux, Inc 595 Anglum Rd. 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 Received2016-12-19
Decision Date2017-03-13
Summary:summary

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