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., Becton, Dickinson & CO and Dade Behring, Inc..

289
Total
289
Cleared
90d
Avg days
1986
Since
289 devices
49–72 of 289
Cleared Feb 09, 2018
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
K173523
Becton, Dickinson and Company
Microbiology · 87d
Cleared Jan 05, 2018
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
K173252
Becton, Dickinson and Company
Microbiology · 87d
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944
bioMerieux, Inc.
Microbiology · 84d
Cleared Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
K172731
bioMerieux, Inc.
Microbiology · 88d
Cleared Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
K162737
bioMerieux, Inc.
Microbiology · 264d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437
bioMerieux, Inc.
Microbiology · 268d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510
bioMerieux, Inc.
Microbiology · 257d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083
bioMerieux, Inc.
Microbiology · 90d
Cleared Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217
bioMerieux, Inc.
Microbiology · 258d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227
bioMerieux, Inc.
Microbiology · 79d
Cleared Apr 15, 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075
bioMerieux, Inc.
Microbiology · 263d
Cleared Jan 15, 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320
Becton, Dickinson and Company
Microbiology · 242d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170
Becton, Dickinson and Company
Microbiology · 82d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149
bioMerieux, Inc.
Microbiology · 46d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468
Becton, Dickinson and Company
Microbiology · 97d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909
Becton, Dickinson and Company
Microbiology · 150d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674
Becton, Dickinson and Company
Microbiology · 122d
Cleared Nov 15, 2013
VITEK 2 AST ST MEROPENEM
K132507
bioMerieux, Inc.
Microbiology · 95d
Cleared Oct 10, 2013
VITEK 2 AST-ST TIGECYCLINE
K131779
bioMerieux, Inc.
Microbiology · 115d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573
bioMerieux, Inc.
Microbiology · 28d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
K123404
Becton, Dickinson & CO
Microbiology · 234d