DCKClass II

C-Reactive Protein, Antigen, Antiserum, And Control

21 CFR 866.5270 / Immunology

DCK is the FDA product code for C-Reactive Protein, Antigen, Antiserum, And Control, a class II device type, regulated under 21 CFR 866.5270. As of 2026-09-10, FDA records hold 126 510(k) clearances under this code, the most recent dated 2025-04-18, and 17 recalls.

Classification record

Product code: DCK
Device name: C-Reactive Protein, Antigen, Antiserum, And Control
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: 126
Ingested recalls: 17

Clearances, product code DCK

By decision year

126 clearances under product code DCK with a decision year between 1976 and 2025, 1996 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DCK by decision year
Year	Clearances
1976	2
1979	4
1981	1
1982	6
1983	2
1984	1
1985	4
1986	6
1987	4
1988	6
1989	7
1990	1
1991	1
1992	5
1993	1
1994	2
1995	8
1996	9
1997	3
1998	4
1999	8
2000	4
2001	4
2002	7
2003	7
2004	4
2005	1
2006	3
2011	1
2012	1
2015	2
2016	1
2017	1
2019	2
2020	1
2022	1
2025	1

Applicants with the most clearances

Product code DCK

Applicants holding the most 510(k) clearances under product code DCK
Applicant	Clearances
Kamiya Biomedical Company, LLC	9
Siemens Healthcare Diagnostics Inc.	7
E.I. Dupont de Nemours & Co., Inc.	5
Syva Co.	5
Beckman Instruments, Inc.	4
Abbott Medical	3
Behring Diagnostics, Inc.	3
Boehringer Mannheim Corp.	3
Hemagen Diagnostics, Inc.	3
Ortho-Clinical Diagnostics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order