JTNClass II

Susceptibility Test Discs, Antimicrobial

21 CFR 866.1620 / Microbiology

JTN is the FDA product code for Susceptibility Test Discs, Antimicrobial, a class II device type, regulated under 21 CFR 866.1620. As of 2026-09-10, FDA records hold 331 510(k) clearances under this code, the most recent dated 2026-08-20, and 47 recalls.

Classification record

Product code: JTN
Device name: Susceptibility Test Discs, Antimicrobial
Regulation: 21 CFR 866.1620
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: Yes
Ingested clearances: 331
Ingested recalls: 47

Clearances, product code JTN

By decision year

331 clearances under product code JTN with a decision year between 1976 and 2026, 2000 the highest year at 54.

Show the numbers

510(k) clearances under FDA product code JTN by decision year
Year	Clearances
1976	1
1980	6
1981	14
1982	8
1983	12
1984	8
1985	12
1986	6
1987	15
1989	24
1990	3
1991	2
1992	16
1993	12
1994	4
1996	7
1997	28
1998	16
1999	21
2000	54
2001	11
2002	1
2004	1
2005	3
2006	2
2007	1
2008	4
2010	3
2011	1
2015	3
2017	3
2018	3
2019	3
2020	2
2021	2
2022	2
2023	4
2024	2
2025	7
2026	4

Applicants with the most clearances

Product code JTN

Applicants holding the most 510(k) clearances under product code JTN
Applicant	Clearances
Hardy Diagnostics	83
BD Becton Dickinson Vacutainer Systems Preanalytic	43
Difco Laboratories, Inc.	41
Oxoid, Ltd.	31
Investigacion Farmaceutica S.A. de C.V.	19
Remel Inc	17
Pasco Laboratories, Inc.	16
Becton Dickinson Microbiology Systems	12
General Diagnostics	12
Becton Dickinson & Co	11

Companies listing this code with FDA

Companies whose registered establishments list this code