JJN · Apparatus, Electrophoresis, For Clinical Use
Clinical Chemistry · 21 CFR 862.2485 · Class 1
Overview
| Product Code | JJN |
|---|---|
| Device Name | Apparatus, Electrophoresis, For Clinical Use |
| Regulation | 21 CFR 862.2485 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924021 | POWER SUPPLY | The Binding Site, Ltd. | Jan 28, 1993 | SESE |
| K924020 | ELECTROPHORESIS TANK | The Binding Site, Ltd. | Dec 28, 1992 | SESE |
| K882344 | ELECTR-TRANSBLOTTER | The W.E.P. Co. | Jan 13, 1989 | SESE |
| K881852 | REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 | Helena Laboratories | Jul 8, 1988 | SESE |
| K882163 | HELENA REP GEL PROCESSOR | Helena Laboratories | Jun 20, 1988 | SESE |
| K873352 | RAPID ELECTROPHORESIS SYSTEM (REP) | Helena Laboratories | Sep 8, 1987 | SESE |
| K864436 | STAVIP 3000 | Roseburg SA | Mar 16, 1987 | SESE |
| K861414 | ELECTROPHORESIS WORK CENTER (EWC) | Helena Laboratories | Aug 26, 1986 | SESE |
| K841407 | ISOGEL AGAROSE | Fmc Corp. | Jul 16, 1985 | SESE |
| K844710 | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD | Logos Scientific, Inc. | Jan 7, 1985 | SESE |
| K842560 | OPTIPHOR-10 | Gelman Sciences, Inc. | Aug 10, 1984 | SESE |
| K842485 | OPTICLEAR | Gelman Sciences, Inc. | Aug 10, 1984 | SESE |
| K841804 | ELVI 70 SAFETY CHAMBER | Logos Scientific, Inc. | May 31, 1984 | SESE |
| K841288 | ELVI 18 | Logos Scientific, Inc. | May 2, 1984 | SESE |
| K830797 | IMMOBILINE SYSTEM LKB 1819 | Lkb Instruments, Inc. | Aug 24, 1983 | SESE |
| K823132 | SARTOPHOR SYSTEM FOR ELECTROPHORESIS | Sartorius Filters, Inc. | Nov 27, 1982 | SESE |
| K822285 | CELLULOSE ACETATE MEMBRANE STRIPS | Sartorius Filters, Inc. | Sep 21, 1982 | SESE |
| K821688 | TITAN GEL HIGH RESOLUTION SERUM PROTEIN | Helena Laboratories | Jun 22, 1982 | SESE |
| K821517 | TITANAN GEL SERUM PROTEIN ELECTROPHORES | Helena Laboratories | Jun 10, 1982 | SESE |
| K821303 | HI-PHORE HIGH RESOLUTION ELECTROPHORES | Gelman Sciences, Inc. | May 12, 1982 | SESE |
Top Applicants
- Helena Laboratories — 8 clearances
- Gelman Sciences, Inc. — 5 clearances
- Corning Medical & Scientific — 3 clearances
- Electrophoresis Corp. of America — 3 clearances
- Logos Scientific, Inc. — 3 clearances
