Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2230](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2230) → DJY — Ion-Exchange Chromatography

# DJY · Ion-Exchange Chromatography

_Clinical Chemistry · 21 CFR 862.2230 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY

## Overview

- **Product Code:** DJY
- **Device Name:** Ion-Exchange Chromatography
- **Regulation:** [21 CFR 862.2230](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2230)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K890113.md) | THE CDI(R) SYSTEM 400 | Cardiovascular Devices, Inc. | May 23, 1989 | SESE |
| [K883615](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K883615.md) | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | Supelco, Inc. | Dec 16, 1988 | SESE |
| [K881361](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K881361.md) | SOLID PHASE EXTRACTION TUBES | Supelco, Inc. | Aug 8, 1988 | SESE |
| [K850963](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K850963.md) | DUPONT PREP TYPE SI EXTRACITON CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Mar 25, 1985 | SESE |
| [K840985](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K840985.md) | TRISACRYL GF 05 & TRISACRYL GF 2000 | Lkb Instruments, Inc. | Apr 19, 1984 | SESE |
| [K832198](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K832198.md) | HC40/HC75 PREPACKED COLUMS | Hamilton Co. | Aug 12, 1983 | SESE |
| [K831289](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K831289.md) | PREFILLED IEC COLUMNS | Berwick Medical Products, Inc. | Jun 16, 1983 | SESE |
| [K830693](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K830693.md) | DUPONT PREP TYPE AS EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | Apr 5, 1983 | SESE |
| [K830692](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K830692.md) | DUPONT PREP OD EXTRACTION CARTRIDE | E.I. Dupont DE Nemours & Co., Inc. | Apr 5, 1983 | SESE |
| [K823697](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K823697.md) | PREP TYPE A EXTRACTION CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | Jan 5, 1983 | SESE |
| [K800061](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY/K800061.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DJY)

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