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510(k) K234000

Device
VITEK 2 AST-Gram Positive Lefamulin (=4 µg/mL)
Applicant
bioMerieux, Inc.
510(k) number
K234000
Product code
LON
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-11
Date received
2023-12-18
Regulation
866.1645
Classification name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anne Rasponi
Address
595 Anglum Rd. Hazelwood MO US 63042 63042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LON#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026-04-15
K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX2026-03-26
K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.2025-08-21
K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company2025-08-08
K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company2025-05-19
K234012VITEK COMPACT PRObioMerieux, Inc.2025-03-14
K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and Company2025-03-06
K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)Becton, Dickinson and Company2024-03-15
K232756ColibríCopan Wasp Srl2023-12-27
K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus PenicillinbioMerieux, Inc.2023-10-23
K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP DaptomycinbioMerieux, Inc.2023-07-05
K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)bioMerieux, Inc.2023-06-26
K211748Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc.2023-04-19
K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN FosfomycinBiomerieux Sa, Inc.2023-03-09
K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN PlazomicinbioMerieux, Inc.2023-02-16