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
217–240 of 289
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 Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655
Becton, Dickinson & CO
Microbiology · 39d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
K032275
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 22, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299
Becton, Dickinson & CO
Microbiology · 59d
Cleared Sep 17, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567
Becton, Dickinson & CO
Microbiology · 28d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399
bioMerieux, Inc.
Microbiology · 37d
Cleared Aug 27, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984
Becton, Dickinson & CO
Microbiology · 62d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 18, 2003
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS
K032131
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
K031943
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)
K031602
Dade Behring, Inc.
Microbiology · 71d
Cleared Jul 30, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML
K031699
Becton, Dickinson & CO
Microbiology · 58d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML
K031912
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 16, 2003
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
K031679
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jul 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
K031589
Becton, Dickinson & CO
Microbiology · 51d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410
bioMerieux, Inc.
Microbiology · 66d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530
Becton, Dickinson & CO
Microbiology · 56d
Cleared Jun 02, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE
K031306
Becton, Dickinson & CO
Microbiology · 39d