Product code CEF
- Device name
- Electrophoretic, Protein Fractionation
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1630
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT | Sebia | 2013-07-26 |
| K972274 | SPIFE | Helena Laboratories | 1997-10-27 |
| K973316 | REP SPE VIS-60/40 KIT | Helena Laboratories | 1997-10-01 |
| K963018 | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS | Bio-Rad | 1997-06-04 |
| K964453 | REP 3 FLUR SPE-60 KIT | Helena Laboratories | 1996-12-23 |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | Morax | 1996-07-17 |
| K951536 | HYDRAGEL PROTEIN(E) KIT | Sebia | 1995-06-30 |
| K930317 | REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 | Helena Laboratories | 1993-08-03 |
| K922053 | REP SPE PLUS (PONCEAU S) SYSTEM | Helena Laboratories | 1992-08-18 |
| K922024 | REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 | Helena Laboratories | 1992-07-23 |
| K913315 | BIO-RAD TOTAL PROTEIN TEST KIT | Bio-Rad | 1992-01-02 |
| K913807 | REP(R) SPE TEMPLATE 30, 16, & 8 | Helena Laboratories | 1991-11-27 |
| K913058 | REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 | Helena Laboratories | 1991-10-30 |
| K912386 | REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 | Helena Laboratories | 1991-07-17 |
| K911468 | REP SPE PLUS (ACID BLUE) SYSTEM | Helena Laboratories | 1991-04-16 |
| K900251 | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 | Helena Laboratories | 1990-02-26 |
| K894585 | REP TM SPE (PONCEAU S) PROCEDURES | Helena Laboratories | 1989-09-13 |
| K893211 | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 | Helena Laboratories | 1989-06-19 |
| K870958 | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 | Helena Laboratories | 1987-04-29 |
| K843397 | CORNING HIGH RESOLUTION PROTEIN ELECTRO | Corning Medical & Scientific | 1984-09-14 |
| K833855 | TITAN GEL SILVER STAIN SYSTEM | Helena Laboratories | 1984-02-27 |
| K811725 | TBG DIAGNOSTIC KIT | Immuno Assay Corp. | 1981-07-10 |
| K802592 | PARAGON SERUM PROTEIN ELECTROPHORESIS | Beckman Instruments, Inc. | 1980-11-12 |
| K781123 | PONCEAU S | Electrophoresis Corp. of America | 1978-08-10 |
| K781120 | TRICHLORACETIC ACID 7.5% | Electrophoresis Corp. of America | 1978-08-10 |
| K781118 | ECA BUFFER PH 8.8 | Electrophoresis Corp. of America | 1978-08-10 |
| K781117 | ECA PREP | Electrophoresis Corp. of America | 1978-08-10 |
| K781116 | ECA BUFFER, PH 816 | Electrophoresis Corp. of America | 1978-08-10 |
| K771720 | AMIDO BLACK CONCENTRATE | Sigma Chemical Co. | 1977-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03607360020593 | CLEAN PROTECT | SEBIA | 2022-12-16 |
| 03607360020586 | CAPICLEAN | SEBIA | 2022-12-16 |
| 03607360020524 | CAPILLARYS/MINICAP WASH SOLUTION (2) | SEBIA | 2022-12-16 |
| 03607360020432 | CAPILLARYS PROTEIN(E) 6 BUFFER | SEBIA | 2022-12-12 |
| 03607360020036 | CAPILLARYS PROTEINE 6 | SEBIA | 2022-12-08 |
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| M5255526030 | SPIFE SPE Hi Res-20 Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525930 | Blade Applicator Kit, 20 Sample (50) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525920 | Blade Applicator Kit, 20 Sample (40) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525820 | SPIFE Split Beta SPE-80, 100 Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525810 | SPIFE Split Beta 80, 100 Bulk Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525770 | SPIFE SPE Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255525640 | SPIFE Split Beta SPE-20, 40, 60 Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
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| M5255524060 | Blade Applicator Kit Split Beta SPIFE 4000 | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52523100 | SPIFE 4000 Split Beta SPE-28 Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255522970 | QuickGel Split Beta SPE 10/20 Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255521360 | QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255520510 | Blade Applicator Kit, Modified-20 Sample (40) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255520500 | Blade Applicator Kit, Modified-20 Sample (50) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255520010 | Blade Applicator Kit, Modified-20 Sample (30) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255520000 | Blade Applicator Kit, Modified-20 Sample (20) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255519990 | Blade Applicator Kit, Modified-20 Sample (10) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530480 | Amido Black Protein Stain (powder) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530410 | TITAN GEL Serum Protein Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530400 | TITAN GEL High Resolution Protein Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530330 | Titan III Cellulose Acetate (76 x 76 mm) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530240 | Titan III Cellulose Acetate (94 x 76 mm) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530230 | Titan III Zip Zone Cellulose Acetate (60 x 76 mm) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52530130 | Titan III Cellulose Acetate (76 x 25 mm) | HELENA LABORATORIES CORPORATION | 2017-03-17 |