VITEK 2 GRAM NEGATIVE MOXIFLOXACIN

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 Moxifloxacin.

Pre-market Notification Details

Device IDK032861
510k NumberK032861
Device Name:VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNancy Weaver
CorrespondentNancy Weaver
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-12
Decision Date2003-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026620288 K032861 000
03573026398484 K032861 000
03573026565930 K032861 000
03573026408398 K032861 000
03573026351502 K032861 000
03573026635480 K032861 000

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