CFF · Class II · 21 CFR 866.5510

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

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

29
Total
29
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
K203184
Sebia
Immunology · 381d
Cleared Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095
Sebia
Immunology · 88d
Cleared May 02, 2019
HYDRASHIFT 2/4 daratumumab
K190851
Sebia
Immunology · 30d
Cleared Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195
Sebia
Immunology · 174d
Cleared Dec 21, 2016
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928
Sebia
Immunology · 160d
Cleared Jan 08, 2015
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483
Sebia
Immunology · 31d
Cleared Aug 24, 2012
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169
Grifols USA, LLC
Immunology · 218d
Cleared Jun 26, 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
K111369
Helena Laboratories Uk, Ltd.
Immunology · 407d
Cleared Oct 13, 2011
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757
Grifols
Immunology · 294d
Cleared Apr 17, 2009
CAPILLARYS IMMUNOTYPING, MODEL 2100
K082085
Sebia
Immunology · 268d
Cleared Apr 14, 2009
MINICAP IMMUNOTYPING, MODEL: 2300
K082388
Sebia
Immunology · 238d
Cleared Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
K061069
Helena Laboratories
Immunology · 80d
Cleared Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162
Helena Laboratories
Immunology · 64d
Cleared Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799
Beckman Coulter, Inc.
Chemistry · 27d
Cleared Nov 30, 1999
K-ASSAY IGM
K993323
Kamiya Biomedical Co.
Immunology · 57d
Cleared Nov 23, 1999
K-ASSAY IGA
K993213
Kamiya Biomedical Co.
Immunology · 60d
Cleared Jun 28, 1999
POLYSLIT IFE KIT
K990998
Helena Laboratories
Immunology · 95d
Cleared Oct 07, 1998
HYDRAGEL 6 CSF KIT
K981048
Morax
Immunology · 201d
Cleared Jan 02, 1998
SPIFE IFE-6
K973040
Helena Laboratories
Chemistry · 141d
Cleared Jul 12, 1996
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669
Morax
Immunology · 143d
Cleared Mar 22, 1994
N-ASSAY TIA IGG
K933972
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Feb 23, 1993
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.
Immunology · 153d
Cleared Nov 02, 1992
REP IMMUNOFIX
K923658
Helena Laboratories
Immunology · 102d

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.