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
97–120 of 289
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126
bioMerieux, Inc.
Microbiology · 59d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346
bioMerieux, Inc.
Microbiology · 213d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383
bioMerieux, Inc.
Microbiology · 93d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852
Becton, Dickinson & CO
Microbiology · 122d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913
Becton, Dickinson & CO
Microbiology · 66d
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
K082538
Becton, Dickinson & CO
Microbiology · 79d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201
bioMerieux, Inc.
Microbiology · 93d
Cleared Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
K073589
Becton, Dickinson & CO
Microbiology · 76d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107
bioMerieux, Inc.
Microbiology · 44d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406
bioMerieux, Inc.
Microbiology · 50d
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433
Becton, Dickinson & CO
Microbiology · 39d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083
bioMerieux, Inc.
Microbiology · 39d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695
bioMerieux, Inc.
Microbiology · 53d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668
bioMerieux, Inc.
Microbiology · 24d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809
Becton, Dickinson & CO
Microbiology · 182d
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 Aug 20, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML
K071623
Becton, Dickinson & CO
Microbiology · 67d
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 Mar 07, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY
K063486
Becton, Dickinson & CO
Microbiology · 110d
Cleared Feb 14, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
K063824
Becton, Dickinson & CO
Microbiology · 50d