DHRClass II

System, Test, Rheumatoid Factor

21 CFR 866.5775 / Immunology

DHR is the FDA product code for System, Test, Rheumatoid Factor, a class II device type, regulated under 21 CFR 866.5775. As of 2026-09-10, FDA records hold 144 510(k) clearances under this code, the most recent dated 2020-05-20, and 15 recalls.

Classification record

Product code: DHR
Device name: System, Test, Rheumatoid Factor
Regulation: 21 CFR 866.5775
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: 144
Ingested recalls: 15

Clearances, product code DHR

By decision year

144 clearances under product code DHR with a decision year between 1976 and 2020, 1996 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code DHR by decision year
Year	Clearances
1976	2
1977	3
1979	4
1980	5
1981	10
1982	3
1983	5
1984	7
1985	5
1986	4
1987	5
1988	4
1989	5
1990	4
1991	2
1992	10
1993	2
1994	3
1995	6
1996	11
1997	9
1998	6
1999	6
2000	5
2002	2
2003	2
2004	3
2006	1
2007	1
2009	1
2010	1
2011	1
2015	1
2016	1
2017	1
2018	1
2019	1
2020	1

Applicants with the most clearances

Product code DHR

Applicants holding the most 510(k) clearances under product code DHR
Applicant	Clearances
Behring Diagnostics, Inc.	5
Beckman Instruments, Inc.	4
Inova Diagnostics, Inc.	4
Kamiya Biomedical Company, LLC	4
Abbott Medical	3
BD Becton Dickinson Vacutainer Systems Preanalytic	3
Bio-Rad	3
Biokit USA, Inc.	3
Cogent Diagnotics, Ltd.	3
Siemens Healthcare Diagnostics Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order