VITEK 2 GRAM NEGATIVE GATIFLOXACIN

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 Negative Gatifloxacin.

Pre-market Notification Details

Device IDK032788
510k NumberK032788
Device Name:VITEK 2 GRAM NEGATIVE GATIFLOXACIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2320
ContactNancy Weaver
CorrespondentNancy Weaver
BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2320
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-08
Decision Date2003-11-04
Summary:summary

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