FDA 510(k) Applications for Medical Device Product Code "CEF"
(Electrophoretic, Protein Fractionation)

FDA 510(k) Number Applicant Device Name Decision Date
K802592 BECKMAN INSTRUMENTS, INC. PARAGON SERUM PROTEIN ELECTROPHORESIS 11/12/1980
K963018 BIO-RAD BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS 06/04/1997
K913315 BIO-RAD BIO-RAD TOTAL PROTEIN TEST KIT 01/02/1992
K843397 CORNING MEDICAL & SCIENTIFIC CORNING HIGH RESOLUTION PROTEIN ELECTRO 09/14/1984
K781118 ELECTROPHORESIS CORP. OF AMERICA ECA BUFFER PH 8.8 08/10/1978
K781116 ELECTROPHORESIS CORP. OF AMERICA ECA BUFFER, PH 816 08/10/1978
K781117 ELECTROPHORESIS CORP. OF AMERICA ECA PREP 08/10/1978
K781123 ELECTROPHORESIS CORP. OF AMERICA PONCEAU S 08/10/1978
K781120 ELECTROPHORESIS CORP. OF AMERICA TRICHLORACETIC ACID 7.5% 08/10/1978
K964453 HELENA LABORATORIES REP 3 FLUR SPE-60 KIT 12/23/1996
K930317 HELENA LABORATORIES REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 08/03/1993
K911468 HELENA LABORATORIES REP SPE PLUS (ACID BLUE) SYSTEM 04/16/1991
K922024 HELENA LABORATORIES REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 07/23/1992
K922053 HELENA LABORATORIES REP SPE PLUS (PONCEAU S) SYSTEM 08/18/1992
K912386 HELENA LABORATORIES REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 07/17/1991
K900251 HELENA LABORATORIES REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 02/26/1990
K973316 HELENA LABORATORIES REP SPE VIS-60/40 KIT 10/01/1997
K893211 HELENA LABORATORIES REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 06/19/1989
K894585 HELENA LABORATORIES REP TM SPE (PONCEAU S) PROCEDURES 09/13/1989
K913807 HELENA LABORATORIES REP(R) SPE TEMPLATE 30, 16, & 8 11/27/1991
K913058 HELENA LABORATORIES REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 10/30/1991
K972274 HELENA LABORATORIES SPIFE 10/27/1997
K870958 HELENA LABORATORIES TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 04/29/1987
K833855 HELENA LABORATORIES TITAN GEL SILVER STAIN SYSTEM 02/27/1984
K811725 IMMUNO ASSAY CORP. TBG DIAGNOSTIC KIT 07/10/1981
K960029 MORAX HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT 07/17/1996
K130500 SEBIA CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT 07/26/2013
K951536 SEBIA HYDRAGEL PROTEIN(E) KIT 06/30/1995
K771720 SIGMA CHEMICAL CO. AMIDO BLACK CONCENTRATE 11/03/1977


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