FDA Product Code CEF: Electrophoretic, Protein Fractionation
Leading manufacturers include Helena Laboratories, Bio-Rad and Sigma Chemical Co..
29
Total
29
Cleared
83d
Avg days
1977
Since
FDA 510(k) Cleared Electrophoretic, Protein Fractionation Devices (Product Code CEF)
29 devices
Cleared
Oct 27, 1997
SPIFE
Helena Laboratories
Chemistry
131d
Cleared
Oct 01, 1997
REP SPE VIS-60/40 KIT
Helena Laboratories
Chemistry
28d
Cleared
Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
Bio-Rad
Chemistry
306d
Cleared
Dec 23, 1996
REP 3 FLUR SPE-60 KIT
Helena Laboratories
Chemistry
47d
Cleared
Aug 03, 1993
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
Helena Laboratories
Chemistry
193d
Cleared
Aug 18, 1992
REP SPE PLUS (PONCEAU S) SYSTEM
Helena Laboratories
Chemistry
106d
Cleared
Jul 23, 1992
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
Helena Laboratories
Chemistry
83d
Cleared
Jan 02, 1992
BIO-RAD TOTAL PROTEIN TEST KIT
Bio-Rad
Chemistry
161d
Cleared
Nov 27, 1991
REP(R) SPE TEMPLATE 30, 16, & 8
Helena Laboratories
Chemistry
93d
Cleared
Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
Helena Laboratories
Chemistry
112d
Cleared
Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
Helena Laboratories
Chemistry
82d
Cleared
Apr 16, 1991
REP SPE PLUS (ACID BLUE) SYSTEM
Helena Laboratories
Chemistry
13d
Cleared
Feb 26, 1990
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
Helena Laboratories
Chemistry
40d
Cleared
Sep 13, 1989
REP TM SPE (PONCEAU S) PROCEDURES
Helena Laboratories
Chemistry
51d
Cleared
Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
Helena Laboratories
Chemistry
53d
Cleared
Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
Helena Laboratories
Chemistry
50d
Cleared
Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
Helena Laboratories
Pathology
112d
Cleared
Nov 12, 1980
PARAGON SERUM PROTEIN ELECTROPHORESIS
Beckman Instruments, Inc.
Chemistry
22d
Cleared
Nov 03, 1977
AMIDO BLACK CONCENTRATE
Sigma Chemical Co.
Chemistry
51d