DBFClass II

Ferritin, Antigen, Antiserum, Control

21 CFR 866.5340 / Immunology

DBF is the FDA product code for Ferritin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5340. As of 2026-09-10, FDA records hold 87 510(k) clearances under this code, the most recent dated 2021-09-14, and 7 recalls.

Classification record

Product code: DBF
Device name: Ferritin, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5340
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: 87
Ingested recalls: 7

Clearances, product code DBF

By decision year

87 clearances under product code DBF with a decision year between 1977 and 2021, 1981 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code DBF by decision year
Year	Clearances
1977	1
1978	1
1979	5
1980	5
1981	7
1982	2
1983	3
1984	2
1986	5
1987	7
1988	3
1989	4
1990	2
1991	2
1992	3
1993	1
1994	2
1995	3
1996	1
1997	3
1998	4
1999	4
2000	1
2002	1
2003	2
2004	1
2005	1
2006	3
2009	1
2010	1
2011	1
2012	1
2014	1
2017	1
2020	1
2021	1

Applicants with the most clearances

Product code DBF

Applicants holding the most 510(k) clearances under product code DBF
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	8
Amersham Corp.	6
Abbott Medical	3
Hybritech, Inc.	3
Kamiya Biomedical Company, LLC	3
BD Becton Dickinson Vacutainer Systems Preanalytic	2
Behring Diagnostics, Inc.	2
Ciba Corning Diagnostics Corp.	2
Corning Medical & Scientific	2
Diagnostic Systems Laboratories, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order