VITEK 2 GRAM NEGATIVE 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 Gram Negative Piperacillin/tazobactam.

Pre-market Notification Details

Device IDK080107
510k NumberK080107
Device Name:VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactNancy Weaver
CorrespondentNancy Weaver
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-15
Decision Date2008-02-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.