VITEK 2 STRPTOCOCCUS CEFTRIAXONE

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 Strptococcus Ceftriaxone.

Pre-market Notification Details

Device IDK122359
510k NumberK122359
Device Name:VITEK 2 STRPTOCOCCUS CEFTRIAXONE
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactThi My Lan Dang
CorrespondentThi My Lan Dang
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-03
Decision Date2012-08-28
Summary:summary

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