Product code JJN
- Device name
- Apparatus, Electrophoresis, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2485
- 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 |
|---|---|---|---|
| K924021 | POWER SUPPLY | The Binding Site, Ltd. | 1993-01-28 |
| K924020 | ELECTROPHORESIS TANK | The Binding Site, Ltd. | 1992-12-28 |
| K882344 | ELECTR-TRANSBLOTTER | The W.E.P. Co. | 1989-01-13 |
| K881852 | REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 | Helena Laboratories | 1988-07-08 |
| K882163 | HELENA REP GEL PROCESSOR | Helena Laboratories | 1988-06-20 |
| K873352 | RAPID ELECTROPHORESIS SYSTEM (REP) | Helena Laboratories | 1987-09-08 |
| K864436 | STAVIP 3000 | Roseburg SA | 1987-03-16 |
| K861414 | ELECTROPHORESIS WORK CENTER (EWC) | Helena Laboratories | 1986-08-26 |
| K841407 | ISOGEL AGAROSE | Fmc Corp. | 1985-07-16 |
| K844710 | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD | Logos Scientific, Inc. | 1985-01-07 |
| K842560 | OPTIPHOR-10 | Gelman Sciences, Inc. | 1984-08-10 |
| K842485 | OPTICLEAR | Gelman Sciences, Inc. | 1984-08-10 |
| K841804 | ELVI 70 SAFETY CHAMBER | Logos Scientific, Inc. | 1984-05-31 |
| K841288 | ELVI 18 | Logos Scientific, Inc. | 1984-05-02 |
| K830797 | IMMOBILINE SYSTEM LKB 1819 | Lkb Instruments, Inc. | 1983-08-24 |
| K823132 | SARTOPHOR SYSTEM FOR ELECTROPHORESIS | Sartorius Filters, Inc. | 1982-11-27 |
| K822285 | CELLULOSE ACETATE MEMBRANE STRIPS | Sartorius Filters, Inc. | 1982-09-21 |
| K821688 | TITAN GEL HIGH RESOLUTION SERUM PROTEIN | Helena Laboratories | 1982-06-22 |
| K821517 | TITANAN GEL SERUM PROTEIN ELECTROPHORES | Helena Laboratories | 1982-06-10 |
| K821303 | HI-PHORE HIGH RESOLUTION ELECTROPHORES | Gelman Sciences, Inc. | 1982-05-12 |
| K803281 | AUTOMATED ELECTROPHORESIS SYSTEM | Helena Laboratories | 1981-01-16 |
| K802396 | GENERAL PROCEDURE AGAROSE FILM | Electrophoresis Corp. of America | 1980-11-26 |
| K802395 | SPECIAL PROCEDURE AQAROSE FILM | Electrophoresis Corp. | 1980-11-26 |
| K801893 | CORNING 60 VOLT POWER SUPPLY | Corning Medical & Scientific | 1980-09-16 |
| K801378 | HIPP BUFFER(NON-BARBITAL), P/N | Gelman Sciences, Inc. | 1980-07-14 |
| K792553 | AGAROSE BARBITAL-EDTA BUFFER | Electrophoresis Corp. of America | 1980-01-29 |
| K792547 | AGAROSE BARBITAL BUFFER | Electrophoresis Corp. of America | 1980-01-29 |
| K791144 | BUFFERIZER | Helena Laboratories | 1979-08-03 |
| K791111 | AUTOMATED ELECTROPHORESES MACHINE | Gelman Sciences, Inc. | 1979-07-30 |
| K772176 | CYSTIC FIBROSIS TESTING INSTRUMENT | Laboratory Equipment Design Co. | 1977-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06438147368907 | Migele Gel Electrophoresis Unit | Wallac Oy | 2018-11-28 |
| 00814695024452 | Micro SSP™ Gel System - 108 Wells | ONE LAMBDA, INC. | 2018-06-15 |
| M52590140 | Zip Zone Sponge Wicks | HELENA LABORATORIES CORPORATION | 2017-03-17 |