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CEF — Electrophoretic, Protein Fractionation Class I

FDA Device Classification

Classification Details

Product Code
CEF
Device Class
Class I
Regulation Number
862.1630
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130500sebiaCAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLJuly 26, 2013
K972274helena laboratoriesSPIFEOctober 27, 1997
K973316helena laboratoriesREP SPE VIS-60/40 KITOctober 1, 1997
K963018bio-radBIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISJune 4, 1997
K964453helena laboratoriesREP 3 FLUR SPE-60 KITDecember 23, 1996
K960029moraxHYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITJuly 17, 1996
K951536sebiaHYDRAGEL PROTEIN(E) KITJune 30, 1995
K930317helena laboratoriesREP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278August 3, 1993
K922053helena laboratoriesREP SPE PLUS (PONCEAU S) SYSTEMAugust 18, 1992
K922024helena laboratoriesREP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175July 23, 1992
K913315bio-radBIO-RAD TOTAL PROTEIN TEST KITJanuary 2, 1992
K913807helena laboratoriesREP(R) SPE TEMPLATE 30, 16, & 8November 27, 1991
K913058helena laboratoriesREP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172October 30, 1991
K912386helena laboratoriesREP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165July 17, 1991
K911468helena laboratoriesREP SPE PLUS (ACID BLUE) SYSTEMApril 16, 1991
K900251helena laboratoriesREP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175February 26, 1990
K894585helena laboratoriesREP TM SPE (PONCEAU S) PROCEDURESSeptember 13, 1989
K893211helena laboratoriesREP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171June 19, 1989
K870958helena laboratoriesTITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091April 29, 1987
K843397corning medical and scientificCORNING HIGH RESOLUTION PROTEIN ELECTROSeptember 14, 1984