DJGClass II

Enzyme Immunoassay, Opiates

21 CFR 862.3650 / Clinical Toxicology

DJG is the FDA product code for Enzyme Immunoassay, Opiates, a class II device type, regulated under 21 CFR 862.3650. As of 2026-09-10, FDA records hold 215 510(k) clearances under this code, the most recent dated 2026-01-29, and 13 recalls.

Classification record

Product code: DJG
Device name: Enzyme Immunoassay, Opiates
Regulation: 21 CFR 862.3650
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: 215
Ingested recalls: 13

Clearances, product code DJG

By decision year

215 clearances under product code DJG with a decision year between 1984 and 2026, 2015 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code DJG by decision year
Year	Clearances
1984	3
1985	1
1987	7
1988	4
1989	4
1990	7
1991	3
1992	4
1993	1
1994	6
1995	7
1996	2
1997	10
1998	4
1999	11
2000	7
2001	8
2002	7
2003	3
2004	6
2005	7
2006	9
2007	2
2008	2
2009	2
2010	6
2011	6
2012	5
2013	5
2014	9
2015	12
2016	2
2017	4
2018	5
2019	3
2020	5
2021	3
2022	2
2023	10
2024	5
2025	3
2026	3

Applicants with the most clearances

Product code DJG

Applicants holding the most 510(k) clearances under product code DJG
Applicant	Clearances
Lin-Zhi International Inc	16
Siemens Healthcare Diagnostics Inc.	14
Microgenics Corporation	13
Immunalysis Corporation	11
Guangzhou Wondfo Biotech Co., Ltd.	8
MEDTOX Diagnostics, Inc.	7
Acon Laboratories, Inc.	6
Phamatech Inc.	6
Abbott Medical	5
Psychemedics Corp.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 86 companies shown, in name order