VITEK 2 AST- Streptococcus Cefotaxime (8 Ug/mL)

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- Streptococcus Cefotaxime (8 Ug/ml).

Pre-market Notification Details

Device IDK210287
510k NumberK210287
Device Name:VITEK 2 AST- Streptococcus Cefotaxime (8 Ug/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
ContactCherece L Jones
CorrespondentCherece L Jones
bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-02
Decision Date2021-10-28

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