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
29 devices
25–29 of 29
Cleared Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424
Helena Laboratories
Chemistry · 60d
Cleared Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Jul 24, 1979
CORNING PARAPROTEIN SCREENING
K790667
Corning Medical & Scientific
Immunology · 109d