VITEK 2 AST-ST CEFOTAXIME

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-st Cefotaxime.

Pre-market Notification Details

Device IDK121863
510k NumberK121863
Device Name:VITEK 2 AST-ST CEFOTAXIME
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
ContactElizabeth Landon
CorrespondentElizabeth Landon
BIOMERIEUX, INC. 100 RODOLPHE ST Durham,  NC  27712
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-26
Decision Date2012-08-16
Summary:summary

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