VITEK 2 GRAM POSITIVE 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 Gram Positive Vancomycin.

Pre-market Notification Details

Device IDK072668
510k NumberK072668
Device Name:VITEK 2 GRAM POSITIVE VANCOMYCIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactJolyn Tenllado
CorrespondentJolyn Tenllado
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-21
Decision Date2007-10-15
Summary:summary

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