VITEK 2 AST - YEAST FLUCONAZOLE

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 - Yeast Fluconazole.

Pre-market Notification Details

Device IDK133817
510k NumberK133817
Device Name:VITEK 2 AST - YEAST FLUCONAZOLE
ClassificationSusceptibility Test Plate, Antifungal
Applicant BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
ContactJocelyn Jennings
CorrespondentJocelyn Jennings
BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
Product CodeNGZ  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-16
Decision Date2014-08-05
Summary:summary

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