FDA Product Code CFF: Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Leading manufacturers include Helena Laboratories, Sebia and Beckman Coulter, Inc..
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
Cleared
Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
Sebia
Immunology
381d
Cleared
Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
Sebia
Immunology
88d
Cleared
May 02, 2019
HYDRASHIFT 2/4 daratumumab
Sebia
Immunology
30d
Cleared
Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
Sebia
Immunology
174d
Cleared
Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
Helena Laboratories
Immunology
80d
Cleared
Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
Helena Laboratories
Immunology
64d
Cleared
Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
Beckman Coulter, Inc.
Chemistry
27d
Cleared
Jun 28, 1999
POLYSLIT IFE KIT
Helena Laboratories
Immunology
95d
Cleared
Jan 02, 1998
SPIFE IFE-6
Helena Laboratories
Chemistry
141d
Cleared
Nov 02, 1992
REP IMMUNOFIX
Helena Laboratories
Immunology
102d
Cleared
Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
Helena Laboratories
Chemistry
60d
Cleared
Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
Beckman Instruments, Inc.
Chemistry
70d
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.