DKZClass II

Enzyme Immunoassay, Amphetamine

21 CFR 862.3100 / Clinical Toxicology

DKZ is the FDA product code for Enzyme Immunoassay, Amphetamine, a class II device type, regulated under 21 CFR 862.3100. As of 2026-09-10, FDA records hold 225 510(k) clearances under this code, the most recent dated 2024-10-30, and 24 recalls.

Classification record

Product code: DKZ
Device name: Enzyme Immunoassay, Amphetamine
Regulation: 21 CFR 862.3100
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: 225
Ingested recalls: 24

Clearances, product code DKZ

By decision year

225 clearances under product code DKZ with a decision year between 1976 and 2024, 2001 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code DKZ by decision year
Year	Clearances
1976	2
1980	1
1984	3
1985	1
1987	7
1988	6
1989	5
1990	7
1991	9
1992	4
1993	6
1994	6
1995	8
1996	3
1997	10
1998	8
1999	8
2000	14
2001	15
2002	9
2003	4
2004	12
2005	11
2006	11
2008	2
2009	2
2010	4
2011	6
2012	5
2013	8
2014	8
2015	5
2016	5
2018	3
2019	3
2020	1
2023	2
2024	1

Applicants with the most clearances

Product code DKZ

Applicants holding the most 510(k) clearances under product code DKZ
Applicant	Clearances
Roche Diagnostic Systems, Inc.	17
Siemens Healthcare Diagnostics Inc.	11
Roche Diagnostics GmbH	10
American Bio Medica Corp.	9
Ucp Biosciences, Inc.	9
Abbott Medical	8
Microgenics Corporation	8
Biosite Incorporated	7
Acon Laboratories, Inc.	6
Alfa Scientific Designs, Inc.	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 82 companies shown, in name order