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) → DKO — Adsorbents, Ion-Exchange

# DKO · Adsorbents, Ion-Exchange

_Clinical Chemistry · 21 CFR 862.2230 · Class 1_

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

## Overview

- **Product Code:** DKO
- **Device Name:** Adsorbents, Ion-Exchange
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K873932](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DKO/K873932.md) | THE EXTRACTOR(TM) | Molecular Biosystems, Inc. | Nov 20, 1987 | SESE |

## Top Applicants

- Molecular Biosystems, Inc. — 1 clearance

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

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