VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

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-gram Positive Inducible Clindamycin Resistance.

Pre-market Notification Details

Device IDK181766
510k NumberK181766
Device Name:VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
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  
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-03
Decision Date2018-12-10
Summary:summary

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