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
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 Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149
bioMerieux, Inc.
Microbiology · 46d
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 Nov 20, 2012
VITEK 2 GRAM NEGATIVE DOXYCYCLINE
K121546
bioMerieux, Inc.
Microbiology · 179d
Cleared Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
K121100
bioMerieux, Inc.
Microbiology · 222d
Cleared Oct 15, 2012
GRAM POSTITVE CLINDAMYCIN
K122547
bioMerieux, Inc.
Microbiology · 55d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863
bioMerieux, Inc.
Microbiology · 51d
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783
bioMerieux, Inc.
Microbiology · 229d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200
bioMerieux, Inc.
Microbiology · 242d