CFFClass II

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

21 CFR 866.5510 / Immunology

CFF is the FDA product code for Immunoelectrophoretic, Immunoglobulins, (G, A, M), a class II device type, regulated under 21 CFR 866.5510. As of 2026-09-10, FDA records hold 29 510(k) clearances under this code, the most recent dated 2021-11-12, and 4 recalls.

Classification record

Product code: CFF
Device name: Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation: 21 CFR 866.5510
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: 29
Ingested recalls: 4

Clearances, product code CFF

By decision year

29 clearances under product code CFF with a decision year between 1979 and 2021, 1999 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code CFF by decision year
Year	Clearances
1979	1
1983	1
1989	1
1992	1
1993	2
1994	1
1996	1
1998	2
1999	3
2000	1
2003	3
2006	1
2009	2
2011	1
2012	2
2015	1
2016	1
2018	1
2019	2
2021	1

Applicants with the most clearances

Product code CFF

Applicants holding the most 510(k) clearances under product code CFF
Applicant	Clearances
Sebia, Inc.	8
Helena Laboratories, Corp.	6
Kamiya Biomedical Company, LLC	2
Morax	2
The Binding Site	2
Siemens Healthcare Diagnostics Inc.	1
Beckman Instruments, Inc.	1
Corning Medical & Scientific	1
Crestat Diagnostics, Inc.	1
Grifols	1

Companies listing this code with FDA

Companies whose registered establishments list this code