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
121–144 of 289
Cleared Jul 27, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
K051478
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 25, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K051350
Dade Behring, Inc.
Microbiology · 62d
Cleared Jul 12, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN
K051311
Dade Behring, Inc.
Microbiology · 54d
Cleared May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K050976
bioMerieux, Inc.
Microbiology · 35d
Cleared May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
K050816
bioMerieux, Inc.
Microbiology · 42d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075
bioMerieux, Inc.
Microbiology · 47d
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076
bioMerieux, Inc.
Microbiology · 37d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002
bioMerieux, Inc.
Microbiology · 45d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230
bioMerieux, Inc.
Microbiology · 38d
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237
bioMerieux, Inc.
Microbiology · 31d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963
bioMerieux, Inc.
Microbiology · 47d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946
bioMerieux, Inc.
Microbiology · 42d
Cleared Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
K041982
bioMerieux, Inc.
Microbiology · 53d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845
bioMerieux, Inc.
Microbiology · 68d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
K031601
Dade Behring, Inc.
Microbiology · 317d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
K033482
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861
bioMerieux, Inc.
Microbiology · 61d
Cleared Nov 04, 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711
bioMerieux, Inc.
Microbiology · 59d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
K032738
bioMerieux, Inc.
Microbiology · 57d
Cleared Oct 31, 2003
VITEK 2 GRAM POSITIVE LINEZOLID
K032766
bioMerieux, Inc.
Microbiology · 56d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399
bioMerieux, Inc.
Microbiology · 37d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865
bioMerieux, Inc.
Microbiology · 57d