LON · Class II · 21 CFR 866.1645

FDA Product Code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Under FDA product code LON, automated antimicrobial susceptibility testing systems are cleared for use in clinical microbiology laboratories.

Unlike manual methods, LON systems automatically inoculate, incubate, and read antimicrobial susceptibility panels, delivering results in hours rather than days. They are essential in high-volume laboratories requiring rapid, standardized antibiotic susceptibility data.

LON devices are Class II medical devices, regulated under 21 CFR 866.1645 and reviewed by the FDA Microbiology panel.

Leading manufacturers include bioMerieux, Inc., Dade Behring, Inc. and Becton, Dickinson and Company.

289
Total
289
Cleared
90d
Avg days
1986
Since
289 devices
25–48 of 289
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931
bioMerieux, Inc.
Microbiology · 169d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023
bioMerieux, Inc.
Microbiology · 113d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
K213241
bioMerieux, Inc.
Microbiology · 148d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849
Biom?rieux, Inc.
Microbiology · 150d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287
bioMerieux, Inc.
Microbiology · 268d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396
bioMerieux, Inc.
Microbiology · 389d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630
bioMerieux, Inc.
Microbiology · 95d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675
bioMerieux, Inc.
Microbiology · 385d
Cleared Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136
bioMerieux, Inc.
Microbiology · 59d
Cleared Sep 28, 2020
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299
bioMerieux, Inc.
Microbiology · 306d
Cleared Aug 30, 2020
LabPro Data Management System
K201405
Beckman Coulter, Inc.
Microbiology · 94d
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590
bioMerieux, Inc.
Microbiology · 53d
Cleared Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
K193572
bioMerieux, Inc.
Microbiology · 81d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567
bioMerieux, Inc.
Microbiology · 53d
Cleared Oct 31, 2019
Vitek Densichek
K192110
bioMerieux, Inc.
Microbiology · 87d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766
bioMerieux, Inc.
Microbiology · 35d
Cleared Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
K190905
Becton, Dickinson and Company
Microbiology · 84d
Cleared Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
K190616
bioMerieux, Inc.
Microbiology · 87d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524
bioMerieux, Inc.
Microbiology · 83d
Cleared Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
K183551
bioMerieux, Inc.
Microbiology · 77d
Cleared Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
K183360
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415
bioMerieux, Inc.
Microbiology · 72d
Cleared Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
K181766
bioMerieux, Inc.
Microbiology · 160d
Cleared Sep 21, 2018
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
K181665
Becton, Dickinson and Company
Microbiology · 88d