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) → KEA — Resins, Ion-Exchange

# KEA · Resins, 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/KEA

## Overview

- **Product Code:** KEA
- **Device Name:** Resins, 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K890997](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K890997.md) | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Atlantic Wholesale, Inc. | Mar 28, 1989 | SESE |
| [K844948](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K844948.md) | SYVA SOLID PHASE COLUMNS | Syva Co. | Aug 29, 1985 | SESE |
| [K842028](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K842028.md) | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | Jun 7, 1984 | SESE |
| [K833320](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K833320.md) | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | Dec 8, 1983 | SESE |
| [K833319](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K833319.md) | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Biosan Laboratories, Inc. | Nov 3, 1983 | SESE |
| [K831027](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K831027.md) | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | May 16, 1983 | SESE |
| [K830918](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K830918.md) | I.E.C COLUMN | Berwick Medical Products, Inc. | Apr 27, 1983 | SESE |
| [K782066](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K782066.md) | EXETRELUT | Mcb Manufacturing Chemists, Inc. | Jan 3, 1979 | SESE |
| [K781728](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KEA/K781728.md) | EXTUBE | Analytichem International, Inc. | Dec 20, 1978 | SESE |

## Top Applicants

- Biosan Laboratories, Inc. — 2 clearances
- Analytichem International, Inc. — 1 clearance
- Atlantic Wholesale, Inc. — 1 clearance
- Berwick Medical Products, Inc. — 1 clearance
- Emd Chemicals, Inc. — 1 clearance

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

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