Panels › Clinical Chemistry › Product code CEF · Class 1
Electrophoretic, Protein Fractionation
Regulation 862.1630
0510(k)s in 12 months (29 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CEF
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 15 | 0 |
| Electrophoresis Corp. of America | 5 | 0 |
| Bio-Rad | 2 | 0 |
| Sebia | 2 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Immuno Assay Corp. | 1 | 0 |
| Morax | 1 | 0 |
| Sigma Chemical Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2013 | K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT Sebia | CEF |
| Oct 27, 1997 | K972274 | SPIFE Helena Laboratories | CEF |
| Oct 1, 1997 | K973316 | REP SPE VIS-60/40 KIT Helena Laboratories | CEF |
| Jun 4, 1997 | K963018 | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS Bio-Rad | CEF |
| Dec 23, 1996 | K964453 | REP 3 FLUR SPE-60 KIT Helena Laboratories | CEF |
| Jul 17, 1996 | K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT Morax | CEF |
| Jun 30, 1995 | K951536 | HYDRAGEL PROTEIN(E) KIT Sebia | CEF |
| Aug 3, 1993 | K930317 | REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 Helena Laboratories | CEF |
| Aug 18, 1992 | K922053 | REP SPE PLUS (PONCEAU S) SYSTEM Helena Laboratories | CEF |
| Jul 23, 1992 | K922024 | REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 Helena Laboratories | CEF |
| Jan 2, 1992 | K913315 | BIO-RAD TOTAL PROTEIN TEST KIT Bio-Rad | CEF |
| Nov 27, 1991 | K913807 | REP(R) SPE TEMPLATE 30, 16, & 8 Helena Laboratories | CEF |
| Oct 30, 1991 | K913058 | REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 Helena Laboratories | CEF |
| Jul 17, 1991 | K912386 | REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 Helena Laboratories | CEF |
| Apr 16, 1991 | K911468 | REP SPE PLUS (ACID BLUE) SYSTEM Helena Laboratories | CEF |
| Feb 26, 1990 | K900251 | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 Helena Laboratories | CEF |
| Sep 13, 1989 | K894585 | REP TM SPE (PONCEAU S) PROCEDURES Helena Laboratories | CEF |
| Jun 19, 1989 | K893211 | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 Helena Laboratories | CEF |
| Apr 29, 1987 | K870958 | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 Helena Laboratories | CEF |
| Sep 14, 1984 | K843397 | CORNING HIGH RESOLUTION PROTEIN ELECTRO Corning Medical & Scientific | CEF |
| Feb 27, 1984 | K833855 | TITAN GEL SILVER STAIN SYSTEM Helena Laboratories | CEF |
| Jul 10, 1981 | K811725 | TBG DIAGNOSTIC KIT Immuno Assay Corp. | CEF |
| Nov 12, 1980 | K802592 | PARAGON SERUM PROTEIN ELECTROPHORESIS Beckman Instruments, Inc. | CEF |
| Aug 10, 1978 | K781123 | PONCEAU S Electrophoresis Corp. of America | CEF |
| Aug 10, 1978 | K781120 | TRICHLORACETIC ACID 7.5% Electrophoresis Corp. of America | CEF |
| Aug 10, 1978 | K781118 | ECA BUFFER PH 8.8 Electrophoresis Corp. of America | CEF |
| Aug 10, 1978 | K781117 | ECA PREP Electrophoresis Corp. of America | CEF |
| Aug 10, 1978 | K781116 | ECA BUFFER, PH 816 Electrophoresis Corp. of America | CEF |
| Nov 3, 1977 | K771720 | AMIDO BLACK CONCENTRATE Sigma Chemical Co. | CEF |
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