DJY · Ion-Exchange Chromatography
Clinical Chemistry · 21 CFR 862.2230 · Class 1
Overview
| Product Code | DJY |
|---|---|
| Device Name | Ion-Exchange Chromatography |
| Regulation | 21 CFR 862.2230 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890113 | THE CDI(R) SYSTEM 400 | Cardiovascular Devices, Inc. | May 23, 1989 | SESE |
| K883615 | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | Supelco, Inc. | Dec 16, 1988 | SESE |
| K881361 | SOLID PHASE EXTRACTION TUBES | Supelco, Inc. | Aug 8, 1988 | SESE |
| K850963 | DUPONT PREP TYPE SI EXTRACITON CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Mar 25, 1985 | SESE |
| K840985 | TRISACRYL GF 05 & TRISACRYL GF 2000 | Lkb Instruments, Inc. | Apr 19, 1984 | SESE |
| K832198 | HC40/HC75 PREPACKED COLUMS | Hamilton Co. | Aug 12, 1983 | SESE |
| K831289 | PREFILLED IEC COLUMNS | Berwick Medical Products, Inc. | Jun 16, 1983 | SESE |
| K830693 | DUPONT PREP TYPE AS EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | Apr 5, 1983 | SESE |
| K830692 | DUPONT PREP OD EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | Apr 5, 1983 | SESE |
| K823697 | PREP TYPE A EXTRACTION CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Jan 5, 1983 | SESE |
| K800061 | BOND ELUT COLUMNS | Analytichem International, Inc. | Mar 12, 1980 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 4 clearances
- Supelco, Inc. — 2 clearances
- Analytichem International, Inc. — 1 clearance
- Berwick Medical Products, Inc. — 1 clearance
- Cardiovascular Devices, Inc. — 1 clearance
