VITEK 2 GRAM POSITIVE MEROPENEM

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 Meropenem.

Pre-market Notification Details

Device IDK050816
510k NumberK050816
Device Name:VITEK 2 GRAM POSITIVE MEROPENEM
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2320
ContactJolyn Tenllado
CorrespondentJolyn Tenllado
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 Received2005-03-31
Decision Date2005-05-12
Summary:summary

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