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

Pre-market Notification Details

Device IDK161217
510k NumberK161217
Device Name:VITEK 2 Gram Negative Ceftriaxone (=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  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-29
Decision Date2017-01-12
Summary:summary

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