DHNClass II

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

21 CFR 866.5100 / Immunology

DHN is the FDA product code for Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a class II device type, regulated under 21 CFR 866.5100. As of 2026-09-10, FDA records hold 110 510(k) clearances under this code, the most recent dated 2022-04-29, and 7 recalls.

Classification record

Product code: DHN
Device name: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation: 21 CFR 866.5100
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 110
Ingested recalls: 7

Clearances, product code DHN

By decision year

110 clearances under product code DHN with a decision year between 1976 and 2022, 2003 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code DHN by decision year
Year	Clearances
1976	4
1977	3
1978	4
1979	8
1980	1
1981	9
1982	8
1983	5
1984	7
1985	5
1986	3
1987	7
1988	3
1989	1
1990	4
1991	1
1993	1
1994	1
1995	1
1996	1
1997	2
1998	6
1999	1
2000	1
2001	1
2002	2
2003	10
2004	1
2007	1
2012	1
2014	1
2015	2
2016	2
2018	1
2022	1

Applicants with the most clearances

Product code DHN

Applicants holding the most 510(k) clearances under product code DHN
Applicant	Clearances
Bio-Rad	14
IMMUNO CONCEPTS, NA, Ltd.	8
Zeus Scientific LLC	6
Meloy Laboratories, Inc.	5
Inova Diagnostics, Inc.	4
Euroimmun US Inc.	3
Amico Lab, Inc.	2
Apple Diagnostic Products	2
Behring Diagnostics, Inc.	2
Calbiochem-Behring Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order