CFF · Class II · 21 CFR 866.5510

FDA Product Code CFF: Immunoelectrophoretic, Immunoglobulins, (g, A, M)

Leading manufacturers include Helena Laboratories, Sebia and The Binding Site, Ltd..

Total

Cleared

141d

Avg days

1979

Since

Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Immunoelectrophoretic, Immunoglobulins, (g, A, M) Devices (Product Code CFF)

29 devices

1–24 of 29

Cleared Nov 12, 2021

HYDRASHIFT 2/4 isatuximab

CAPI 3 Immunotyping, Capillarys 3 Tera

HYDRASHIFT 2/4 daratumumab

HYDRASHIFT 2/4 daratumumab, daratumumab Control

SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100

K002799

Beckman Coulter, Inc.

Kamiya Biomedical Co.

Kamiya Biomedical Co.

IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC

K924767

The Binding Site, Ltd.

Immunology · 153d

Cleared Feb 23, 1993

IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC

K924769

The Binding Site, Ltd.

REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178

PARAGON IMMUNOELECTROPHORESIS REAGENT

K823884

Beckman Instruments, Inc.

Chemistry · 70d

Cleared Jul 24, 1979

CORNING PARAPROTEIN SCREENING

K790667

Corning Medical & Scientific

Immunology · 109d

About Product Code CFF - Regulatory Context

510(k) Submission Activity

29 total 510(k) submissions under product code CFF since 1979, with 29 receiving FDA clearance (average review time: 141 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Nov 12, 2021

Product Code Info

Code	CFF
Device class	Class II
CFR	21 CFR 866.5510
Panel	Immunology

Verify on FDA.gov

View CFF classification on FDA.gov →