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LON

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Product code
LON
Device name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class
Class 2
21 CFR
21 CFR 866.1645
Medical specialty
Microbiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
11
Summaries archived here
11 (direct download)
510(k) clearances (all years, FDA)
289 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (11)

Last three years. Most recent: 2026-04-15.

NumberDecision dateApplicantDevice nameSummary
K2602822026-04-15bioMerieux, Inc.VITEK 2 AST-Streptococcus Inducible Clindamycin Resi…PDF
K2602812026-03-26BIOMERIEUXVITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 …PDF
K2515792025-08-21bioMerieux, Inc.VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)PDF
K2517132025-08-08Becton, Dickinson and CompanyBD Phoenix Automated Microbiology System - GN Eravac…PDF
K2504472025-05-19Becton, Dickinson and CompanyBD Phoenix™ Automated Microbiology System - GN Imipe…PDF
K2340122025-03-14bioMerieux, Inc.VITEK COMPACT PROPDF
K2503442025-03-06Becton, Dickinson and CompanyBD Phoenix™ Automated Microbiology SystemPDF
K2339862024-03-15Becton, Dickinson and CompanyBD Phoenix™ Automated Microbiology System - GN Cipro…PDF
K2340002024-03-11bioMerieux, Inc.VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg…PDF
K2327562023-12-27Copan Wasp SrlColibríPDF
K2322012023-10-23bioMerieux, Inc.VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µ…PDF

11 summaries are archived here for direct download.

Official FDA classification page: LON
Classification and pathway per current FDA publications. Data from openFDA (CC0).