VITEK 2 STREPTOCOCCUS ERYTHROMYCIN

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 Erythromycin.

Pre-market Notification Details

Device IDK111976
510k NumberK111976
Device Name:VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
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 Received2011-07-12
Decision Date2012-02-17
Summary:summary

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