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
97–120 of 289
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038
bioMerieux, Inc.
Microbiology · 49d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
K071317
Dade Behring, Inc.
Microbiology · 102d
Cleared Jul 18, 2007
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346
Dade Behring, Inc.
Microbiology · 162d
Cleared Jun 26, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268
Dade Behring, Inc.
Microbiology · 50d
Cleared May 21, 2007
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K071076
Dade Behring, Inc.
Microbiology · 35d
Cleared May 11, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
K070860
Dade Behring, Inc.
Microbiology · 44d
Cleared Feb 08, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML)
K063564
Dade Behring, Inc.
Microbiology · 72d
Cleared Jan 19, 2007
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K063597
bioMerieux, Inc.
Microbiology · 46d
Cleared Jan 11, 2007
VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
K063623
bioMerieux, Inc.
Microbiology · 36d
Cleared Dec 21, 2006
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K063492
bioMerieux, Inc.
Microbiology · 34d
Cleared Dec 08, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
K063365
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 08, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE
K063366
Dade Behring, Inc.
Microbiology · 31d
Cleared Nov 20, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML
K062938
Dade Behring, Inc.
Microbiology · 53d
Cleared Oct 20, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
K062705
Dade Behring, Inc.
Microbiology · 39d
Cleared Jun 20, 2006
VITEK 2 GRAM POSITIVE VRSA SCREEN
K061347
bioMerieux, Inc.
Microbiology · 36d
Cleared Mar 23, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)
K060312
Dade Behring, Inc.
Microbiology · 43d
Cleared Feb 24, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)
K053504
Dade Behring, Inc.
Microbiology · 70d
Cleared Feb 03, 2006
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
K060088
Dade Behring, Inc.
Microbiology · 22d
Cleared Dec 14, 2005
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
K053097
bioMerieux, Inc.
Microbiology · 41d
Cleared Dec 01, 2005
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K053186
bioMerieux, Inc.
Microbiology · 17d
Cleared Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
K052656
bioMerieux, Inc.
Microbiology · 42d
Cleared Oct 26, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K052346
Dade Behring, Inc.
Microbiology · 58d
Cleared Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
K052311
bioMerieux, Inc.
Microbiology · 36d
Cleared Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
K051849
bioMerieux, Inc.
Microbiology · 40d