VITEK 2 AST-GN Amikacin (=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-gn Amikacin (=64 Ug/ml).

Pre-market Notification Details

Device IDK172731
510k NumberK172731
Device Name:VITEK 2 AST-GN Amikacin (=64 Ug/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
ContactEsther Hernandez
CorrespondentEsther Hernandez
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 Received2017-09-11
Decision Date2017-12-08
Summary:summary

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