DLJClass II

Calibrators, Drug Specific

21 CFR 862.3200 / Clinical Toxicology

DLJ is the FDA product code for Calibrators, Drug Specific, a class II device type, regulated under 21 CFR 862.3200. As of 2026-09-10, FDA records hold 123 510(k) clearances under this code, the most recent dated 2013-08-08, and 5 recalls.

Classification record

Product code: DLJ
Device name: Calibrators, Drug Specific
Regulation: 21 CFR 862.3200
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 123
Ingested recalls: 5

Clearances, product code DLJ

By decision year

123 clearances under product code DLJ with a decision year between 1977 and 2013, 1987 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code DLJ by decision year
Year	Clearances
1977	4
1978	1
1979	3
1980	1
1981	2
1982	2
1983	7
1984	7
1985	3
1986	3
1987	18
1988	4
1989	15
1990	5
1991	4
1992	3
1993	4
1994	2
1995	3
1996	4
1997	4
1998	3
1999	2
2001	2
2002	4
2003	3
2004	1
2005	1
2006	5
2008	1
2009	1
2013	1

Applicants with the most clearances

Product code DLJ

Applicants holding the most 510(k) clearances under product code DLJ
Applicant	Clearances
E.I. Dupont de Nemours & Co., Inc.	21
Siemens Healthcare Diagnostics Inc.	11
Innotron of Oregon, Inc.	10
Roche Diagnostic Systems, Inc.	8
Syva Co.	8
Diagnostic Reagents, Inc.	7
Em Diagnostic Systems, Inc.	6
Syva Co.	6
Colony Laboratories, Inc.	5
Microgenics Corporation	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order