CEF · Class I · 21 CFR 862.1630

FDA Product Code CEF: Electrophoretic, Protein Fractionation

Leading manufacturers include Helena Laboratories, Electrophoresis Corp. of America and Bio-Rad.

29
Total
29
Cleared
83d
Avg days
1977
Since

FDA 510(k) Cleared Electrophoretic, Protein Fractionation Devices (Product Code CEF)

29 devices
1–24 of 29
Cleared Jul 26, 2013
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
K130500
Sebia
Immunology · 150d
Cleared Oct 27, 1997
SPIFE
K972274
Helena Laboratories
Chemistry · 131d
Cleared Oct 01, 1997
REP SPE VIS-60/40 KIT
K973316
Helena Laboratories
Chemistry · 28d
Cleared Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018
Bio-Rad
Chemistry · 306d
Cleared Dec 23, 1996
REP 3 FLUR SPE-60 KIT
K964453
Helena Laboratories
Chemistry · 47d
Cleared Jul 17, 1996
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029
Morax
Chemistry · 197d
Cleared Jun 30, 1995
HYDRAGEL PROTEIN(E) KIT
K951536
Sebia
Chemistry · 88d
Cleared Aug 03, 1993
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
K930317
Helena Laboratories
Chemistry · 193d
Cleared Aug 18, 1992
REP SPE PLUS (PONCEAU S) SYSTEM
K922053
Helena Laboratories
Chemistry · 106d
Cleared Jul 23, 1992
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
K922024
Helena Laboratories
Chemistry · 83d
Cleared Jan 02, 1992
BIO-RAD TOTAL PROTEIN TEST KIT
K913315
Bio-Rad
Chemistry · 161d
Cleared Nov 27, 1991
REP(R) SPE TEMPLATE 30, 16, & 8
K913807
Helena Laboratories
Chemistry · 93d
Cleared Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
K913058
Helena Laboratories
Chemistry · 112d
Cleared Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
K912386
Helena Laboratories
Chemistry · 82d
Cleared Apr 16, 1991
REP SPE PLUS (ACID BLUE) SYSTEM
K911468
Helena Laboratories
Chemistry · 13d
Cleared Feb 26, 1990
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
K900251
Helena Laboratories
Chemistry · 40d
Cleared Sep 13, 1989
REP TM SPE (PONCEAU S) PROCEDURES
K894585
Helena Laboratories
Chemistry · 51d
Cleared Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211
Helena Laboratories
Chemistry · 53d
Cleared Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
K870958
Helena Laboratories
Chemistry · 50d
Cleared Sep 14, 1984
CORNING HIGH RESOLUTION PROTEIN ELECTRO
K843397
Corning Medical & Scientific
Chemistry · 16d
Cleared Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
K833855
Helena Laboratories
Pathology · 112d
Cleared Nov 12, 1980
PARAGON SERUM PROTEIN ELECTROPHORESIS
K802592
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Aug 10, 1978
ECA BUFFER, PH 816
K781116
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
ECA PREP
K781117
Electrophoresis Corp. of America
Chemistry · 38d

About Product Code CEF - Regulatory Context