VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE

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 Trimethoprim/sulfamethoazole.

Pre-market Notification Details

Device IDK110106
510k NumberK110106
Device Name:VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
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 Received2011-01-13
Decision Date2011-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026552152 K110106 000

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