VITEK 2 AST-Gram Negative Minocycline (= 32 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-gram Negative Minocycline (= 32 Ug/ml).

Pre-market Notification Details

Device IDK183551
510k NumberK183551
Device Name:VITEK 2 AST-Gram Negative Minocycline (= 32 Ug/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc. 595 Anglum Road Hazelwood,  MO  63042
ContactCraig Buehler
CorrespondentCraig Buehler
bioMerieux, Inc. 595 Anglum Road 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 Received2018-12-20
Decision Date2019-03-07

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