VITEK 2 AST STREPTOCOCUS VANCOMYCIN

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 Streptococus Vancomycin.

Pre-market Notification Details

Device IDK121100
510k NumberK121100
Device Name:VITEK 2 AST STREPTOCOCUS VANCOMYCIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactJocelyn Jennings
CorrespondentJocelyn Jennings
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-11
Decision Date2012-11-19
Summary:summary

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