LDJClass II

Enzyme Immunoassay, Cannabinoids

21 CFR 862.3870 / Clinical Toxicology

LDJ is the FDA product code for Enzyme Immunoassay, Cannabinoids, a class II device type, regulated under 21 CFR 862.3870. As of 2026-09-10, FDA records hold 150 510(k) clearances under this code, the most recent dated 2024-01-17, and 15 recalls.

Classification record

Product code: LDJ
Device name: Enzyme Immunoassay, Cannabinoids
Regulation: 21 CFR 862.3870
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 150
Ingested recalls: 15

Clearances, product code LDJ

By decision year

150 clearances under product code LDJ with a decision year between 1981 and 2024, 2000 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code LDJ by decision year
Year	Clearances
1981	1
1984	4
1985	1
1986	1
1987	11
1988	8
1989	3
1990	8
1991	6
1992	3
1993	4
1994	8
1995	4
1996	5
1997	6
1998	7
1999	6
2000	12
2001	9
2002	5
2003	2
2004	5
2005	4
2006	3
2008	2
2009	1
2011	4
2012	4
2013	3
2014	2
2015	3
2016	1
2019	1
2023	1
2024	2

Applicants with the most clearances

Product code LDJ

Applicants holding the most 510(k) clearances under product code LDJ
Applicant	Clearances
Roche Diagnostic Systems, Inc.	11
Syva Co.	9
Abbott Medical	8
Siemens Healthcare Diagnostics Inc.	5
Microgenics Corporation	5
Acon Laboratories, Inc.	4
Amedica Biotech, Inc.	4
American Bio Medica Corp.	3
Beckman Instruments, Inc.	3
Branan Medical Corp.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 89 companies shown, in name order