Electrophoretic, Protein Fractionation

FDA product code CEF · Class I (low risk) · 21 CFR 862.1630 · Clinical Chemistry

29510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K130500Capillarys Immunotyping, Capillarys 2 Instrument, It/If Control, Capillarys 2 Flex…CEF · Traditional Sebia07/26/2013SE
K972274SpifeCEF · Traditional Helena Laboratories10/27/1997SE
K973316Rep Spe VIS-60/40 KitCEF · Traditional Helena Laboratories10/01/1997SE
K963018Bio-Rad Serum Proteins by Capillary ElectrophoresisCEF · Traditional Bio-Rad06/04/1997SE
K964453Rep 3 Flur SPE-60 KitCEF · Traditional Helena Laboratories12/23/1996SE
K960029Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein KitCEF · Traditional Morax07/17/1996SE
K951536Hydragel Protein(E) KitCEF · Traditional Sebia06/30/1995SE
K930317Rep Spe Hi-Res Template System, Cat 3276/3277/3278CEF · Traditional Helena Laboratories08/03/1993SE
K922053Rep Spe Plus (Ponceau S) SystemCEF · Traditional Helena Laboratories08/18/1992SE
K922024Rep Spe Plus (Acid Blue) System,# 3173/3174/3175CEF · Traditional Helena Laboratories07/23/1992SE
K913315Bio-Rad Total Protein Test KitCEF · Traditional Bio-Rad01/02/1992SE
K913807Rep(R) Spe Template 30, 16, & 8CEF · Traditional Helena Laboratories11/27/1991SE
K913058Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172CEF · Traditional Helena Laboratories10/30/1991SE
K912386Rep Spe Plus (Ponceau S) System, 3163, 3164 & 3165CEF · Traditional Helena Laboratories07/17/1991SE
K911468Rep Spe Plus (Acid Blue) SystemCEF · Traditional Helena Laboratories04/16/1991SE
K900251Rep Spe PLUS-8 (Ponceau S) 3165, PLUS-8 No. 3175CEF · Traditional Helena Laboratories02/26/1990SE
K894585Rep TM Spe (Ponceau S) ProceduresCEF · Traditional Helena Laboratories09/13/1989SE
K893211Rep SPE-8 Kit, Cat.# 3172/REP SPE-16 Kit CAT.#3171CEF · Traditional Helena Laboratories06/19/1989SE
K870958Titan Gel Multi-Slot SP-17 Kit Cat. No. 3091CEF · Traditional Helena Laboratories04/29/1987SE
K843397Corning High Resolution Protein ElectroCEF · Traditional Corning Medical & Scientific09/14/1984SE
K833855Titan Gel Silver Stain SystemCEF · Traditional Helena Laboratories02/27/1984SE
K811725TBG Diagnostic KitCEF · Traditional Immuno Assay Corp.07/10/1981SE
K802592Paragon Serum Protein ElectrophoresisCEF · Traditional Beckman Instruments, Inc.11/12/1980SE
K781123Ponceau SCEF · Traditional Electrophoresis Corp. of America08/10/1978SE
K781120Trichloracetic Acid 7.5%CEF · Traditional Electrophoresis Corp. of America08/10/1978SE
K781118Eca Buffer PH 8.8CEF · Traditional Electrophoresis Corp. of America08/10/1978SE
K781117Eca PrepCEF · Traditional Electrophoresis Corp. of America08/10/1978SE
K781116Eca Buffer, PH 816CEF · Traditional Electrophoresis Corp. of America08/10/1978SE
K771720Amido Black ConcentrateCEF · Traditional Sigma Chemical Co.11/03/1977SE