Atlas FDA

CEF

29 FDA 510(k) clearances · Product code

51 daysmedian time to decision
193 days90th percentile
29clearances measured

FDA profile

Official device name
Electrophoretic, Protein Fractionation
Device class
Class I (low risk)
Regulation
21 CFR 862.1630
Medical specialty
Clinical Chemistry
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500)Sebia2013-07-26
SPIFE (K972274)Helena Laboratories1997-10-27
REP SPE VIS-60/40 KIT (K973316)Helena Laboratories1997-10-01
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018)Bio-Rad1997-06-04
REP 3 FLUR SPE-60 KIT (K964453)Helena Laboratories1996-12-23
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (K960029)Morax1996-07-17
HYDRAGEL PROTEIN(E) KIT (K951536)Sebia1995-06-30
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (K930317)Helena Laboratories1993-08-03
REP SPE PLUS (PONCEAU S) SYSTEM (K922053)Helena Laboratories1992-08-18
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (K922024)Helena Laboratories1992-07-23
BIO-RAD TOTAL PROTEIN TEST KIT (K913315)Bio-Rad1992-01-02
REP(R) SPE TEMPLATE 30, 16, & 8 (K913807)Helena Laboratories1991-11-27
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)Helena Laboratories1991-10-30
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (K912386)Helena Laboratories1991-07-17
REP SPE PLUS (ACID BLUE) SYSTEM (K911468)Helena Laboratories1991-04-16
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 (K900251)Helena Laboratories1990-02-26
REP TM SPE (PONCEAU S) PROCEDURES (K894585)Helena Laboratories1989-09-13
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)Helena Laboratories1989-06-19
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 (K870958)Helena Laboratories1987-04-29
CORNING HIGH RESOLUTION PROTEIN ELECTRO (K843397)Corning Medical & Scientific1984-09-14
TITAN GEL SILVER STAIN SYSTEM (K833855)Helena Laboratories1984-02-27
TBG DIAGNOSTIC KIT (K811725)Immuno Assay Corp.1981-07-10
PARAGON SERUM PROTEIN ELECTROPHORESIS (K802592)Beckman Instruments, Inc.1980-11-12
ECA PREP (K781117)Electrophoresis Corp. of America1978-08-10
TRICHLORACETIC ACID 7.5% (K781120)Electrophoresis Corp. of America1978-08-10
ECA BUFFER, PH 816 (K781116)Electrophoresis Corp. of America1978-08-10
ECA BUFFER PH 8.8 (K781118)Electrophoresis Corp. of America1978-08-10
PONCEAU S (K781123)Electrophoresis Corp. of America1978-08-10
AMIDO BLACK CONCENTRATE (K771720)Sigma Chemical Co.1977-11-03

Track CEF automatically

Every clearance here is in the API, with alerts when new ones post.