DKBClass II

Calibrators, Drug Mixture

21 CFR 862.3200 / Clinical Toxicology

DKB is the FDA product code for Calibrators, Drug Mixture, a class II device type, regulated under 21 CFR 862.3200. As of 2026-09-10, FDA records hold 94 510(k) clearances under this code, the most recent dated 2014-11-25, and 9 recalls.

Classification record

Product code: DKB
Device name: Calibrators, Drug Mixture
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: 94
Ingested recalls: 9

Clearances, product code DKB

By decision year

94 clearances under product code DKB with a decision year between 1979 and 2014, 1991 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code DKB by decision year
Year	Clearances
1979	1
1980	1
1981	3
1982	3
1983	1
1984	7
1986	1
1987	2
1988	4
1989	4
1990	5
1991	10
1992	2
1993	3
1994	9
1995	3
1996	4
1997	2
1998	7
1999	2
2000	1
2001	1
2002	2
2003	4
2004	1
2005	1
2006	3
2009	2
2011	2
2012	1
2014	2

Applicants with the most clearances

Product code DKB

Applicants holding the most 510(k) clearances under product code DKB
Applicant	Clearances
Roche Diagnostic Systems, Inc.	10
Syva Co.	10
Siemens Healthcare Diagnostics Inc.	9
Syva Co.	8
Diagnostic Reagents, Inc.	6
Microgenics Corporation	6
Roche Diagnostics GmbH	5
Boehringer Mannheim Corp.	3
E.I. Dupont de Nemours & Co., Inc.	3
Hycor Biomedical	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order