DCNClass II

System, Test, C-Reactive Protein

21 CFR 866.5270 / Immunology

DCN is the FDA product code for System, Test, C-Reactive Protein, a class II device type, regulated under 21 CFR 866.5270. As of 2026-09-10, FDA records hold 70 510(k) clearances under this code, the most recent dated 2023-11-27, and 5 recalls.

Classification record

Product code: DCN
Device name: System, Test, C-Reactive Protein
Regulation: 21 CFR 866.5270
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: 70
Ingested recalls: 5

Clearances, product code DCN

By decision year

70 clearances under product code DCN with a decision year between 1977 and 2023, 2002 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code DCN by decision year
Year	Clearances
1977	2
1979	1
1981	3
1982	2
1983	3
1984	4
1986	3
1987	1
1988	4
1989	2
1990	3
1991	2
1993	1
1994	1
1995	1
1996	1
1998	1
1999	2
2000	2
2001	5
2002	6
2003	2
2004	1
2005	1
2006	1
2007	1
2008	2
2009	3
2010	1
2012	1
2017	1
2018	3
2020	1
2023	2

Applicants with the most clearances

Product code DCN

Applicants holding the most 510(k) clearances under product code DCN
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	7
Good Biotech Corp.	4
Roche Diagnostics GmbH	4
The Binding Site Group Ltd.	3
Abbott Medical	2
Behring Diagnostics, Inc.	2
Biokit USA, Inc.	2
Kallestad Diag, A Div. of Erbamont, Inc.	2
OLYMPUS Corporation of the Americas	2
Syn-Kit, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order