VITEK 2 AST- Gram Negative Polymyxin B (=16 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 Polymyxin B (=16 Ug/ml).

Pre-market Notification Details

Device IDK193567
510k NumberK193567
Device Name:VITEK 2 AST- Gram Negative Polymyxin B (=16 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 Received2019-12-23
Decision Date2020-02-14

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