DJRClass II

Enzyme Immunoassay, Methadone

21 CFR 862.3620 / Clinical Toxicology

DJR is the FDA product code for Enzyme Immunoassay, Methadone, a class II device type, regulated under 21 CFR 862.3620. As of 2026-09-10, FDA records hold 63 510(k) clearances under this code, the most recent dated 2019-10-04, and 7 recalls.

Classification record

Product code: DJR
Device name: Enzyme Immunoassay, Methadone
Regulation: 21 CFR 862.3620
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: 63
Ingested recalls: 7

Clearances, product code DJR

By decision year

63 clearances under product code DJR with a decision year between 1984 and 2019, 2001 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code DJR by decision year
Year	Clearances
1984	2
1985	1
1987	3
1988	1
1991	1
1992	2
1993	3
1994	3
1995	2
1996	1
1997	2
1998	3
1999	2
2000	4
2001	7
2002	5
2003	4
2004	1
2006	4
2009	1
2010	3
2013	1
2015	3
2016	1
2017	1
2018	1
2019	1

Applicants with the most clearances

Product code DJR

Applicants holding the most 510(k) clearances under product code DJR
Applicant	Clearances
Lin-Zhi International Inc	5
Abbott Medical	3
Siemens Healthcare Diagnostics Inc.	3
Diagnostic Reagents, Inc.	3
Randox Laboratories, Limited	3
Alfa Scientific Designs, Inc.	2
American Bio Medica Corp.	2
Beckman Instruments, Inc.	2
Biosite Incorporated	2
Microgenics Corporation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 70 companies shown, in name order