VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM

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-gn Piperacillin/tazobactam.

Pre-market Notification Details

Device IDK113200
510k NumberK113200
Device Name:VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactSandra Perreand
CorrespondentSandra Perreand
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-31
Decision Date2012-06-29

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