VITEK 2 AST ST 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 Ast St Meropenem.

Pre-market Notification Details

Device IDK132507
510k NumberK132507
Device Name:VITEK 2 AST ST MEROPENEM
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNathan Hardesty
CorrespondentNathan Hardesty
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-12
Decision Date2013-11-15
Summary:summary

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