VITEK 2 GRAM NEGATIVE TIGECYCLINE

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 Tigecycline.

Pre-market Notification Details

Device IDK052311
510k NumberK052311
Device Name:VITEK 2 GRAM NEGATIVE TIGECYCLINE
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 Received2005-08-24
Decision Date2005-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026374549 K052311 000

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