VITEK 2 AST-YS Caspofungin =8 Ug/mL

Susceptibility Test Plate, Antifungal

BIOMERIEUX INC

The following data is part of a premarket notification filed by Biomerieux Inc with the FDA for Vitek 2 Ast-ys Caspofungin =8 Ug/ml.

Pre-market Notification Details

Device IDK151817
510k NumberK151817
Device Name:VITEK 2 AST-YS Caspofungin =8 Ug/mL
ClassificationSusceptibility Test Plate, Antifungal
Applicant BIOMERIEUX INC 595 ANGLUM ROAD Hazelwood,  MO  63042
ContactKaren Russell
CorrespondentKaren Russell
BIOMERIEUX INC 595 ANGLUM ROAD Hazelwood,  MO  63042
Product CodeNGZ  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-06
Decision Date2016-02-18
Summary:summary

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