VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/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 Ciprofloxacin (?0.06 - ?4 µg/ml).

Pre-market Notification Details

Device IDK214023
510k NumberK214023
Device Name:VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
ContactKyle J Olney
CorrespondentKyle J Olney
bioMerieux, Inc 595 Anglum Rd. Hazelwood,  MO  63042
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-22
Decision Date2022-04-14

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