VITEK 2 AST-GN Tigecycline (8 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 Tigecycline (8 Ug/ml).

Pre-market Notification Details

Device IDK163006
510k NumberK163006
Device Name:VITEK 2 AST-GN Tigecycline (8 Ug/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc. 595 Anglum Rd. Hazelwood,  MO  63042
ContactJennifer Jines
CorrespondentJennifer Jines
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 Received2016-10-28
Decision Date2017-01-24
Summary:summary

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