VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

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 Streptococcus Levofloxacin.

Pre-market Notification Details

Device IDK112228
510k NumberK112228
Device Name:VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactJennifer Chia-hsuan Lin
CorrespondentJennifer Chia-hsuan Lin
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-03
Decision Date2011-10-03
Summary:summary

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