LONClass II

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

21 CFR 866.1645 / Microbiology

LON is the FDA product code for System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a class II device type, regulated under 21 CFR 866.1645. As of 2026-09-10, FDA records hold 289 510(k) clearances under this code, the most recent dated 2026-04-15, and 237 recalls.

Classification record

Product code: LON
Device name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation: 21 CFR 866.1645
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 289
Ingested recalls: 238

Clearances, product code LON

By decision year

289 clearances under product code LON with a decision year between 1986 and 2026, 2005 the highest year at 38.

Show the numbers

510(k) clearances under FDA product code LON by decision year
Year	Clearances
1986	1
1989	1
2002	34
2003	36
2004	22
2005	38
2006	30
2007	19
2008	7
2009	8
2010	1
2011	8
2012	10
2013	7
2014	4
2016	3
2017	10
2018	4
2019	8
2020	5
2021	5
2022	8
2023	11
2024	2
2025	5
2026	2

Applicants with the most clearances

Product code LON

Applicants holding the most 510(k) clearances under product code LON
Applicant	Clearances
Becton Dickinson & Co	122
bioMerieux, Inc.	116
Siemens Healthcare Diagnostics Inc.	39
Lee Laboratories, Inc.	3
Copan WASP	2
Dade Microscan, Inc.	2
Selux Diagnostics, Inc.	2
BD Becton Dickinson Vacutainer Systems Preanalytic	1
Mct Medical, Inc.	1
Trinity Biotech USA	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order