DFCClass II

Lipoprotein, Low-Density, Antigen, Antiserum, Control

21 CFR 866.5600 / Immunology

DFC is the FDA product code for Lipoprotein, Low-Density, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5600. As of 2026-09-10, FDA records hold 43 510(k) clearances under this code, the most recent dated 2026-06-16, and 6 recalls.

Classification record

Product code: DFC
Device name: Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5600
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: 43
Ingested recalls: 6

Clearances, product code DFC

By decision year

43 clearances under product code DFC with a decision year between 1977 and 2026, 2000 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DFC by decision year
Year	Clearances
1977	2
1978	1
1987	1
1988	2
1990	2
1993	1
1995	1
1997	1
1998	1
1999	7
2000	9
2001	2
2002	4
2005	1
2007	1
2009	1
2012	2
2018	1
2022	1
2025	1
2026	1

Applicants with the most clearances

Product code DFC

Applicants holding the most 510(k) clearances under product code DFC
Applicant	Clearances
FUJIFILM Healthcare Americas Corporation	9
Roche Diagnostics GmbH	5
Siemens Healthcare Diagnostics Inc.	3
Diasorin Inc.	3
Diazyme Laboratories, Inc.	2
Kallestad Diag, A Div. of Erbamont, Inc.	2
Kamiya Biomedical Company, LLC	2
Abbott Medical	1
Axis Biochemicals, ASA	1
Binax, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order