Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2260](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2260) → LEQ — Detectors, Electrochemical, Liquid Chromatography

# LEQ · Detectors, Electrochemical, Liquid Chromatography

_Clinical Chemistry · 21 CFR 862.2260 · Class 1_

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

## Overview

- **Product Code:** LEQ
- **Device Name:** Detectors, Electrochemical, Liquid Chromatography
- **Regulation:** [21 CFR 862.2260](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2260)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

## 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 § 862.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K962574](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LEQ/K962574.md) | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | Waters Corporation | Jul 22, 1996 | SESE |
| [K903231](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LEQ/K903231.md) | COULOCHEM II | Esa, Inc. | Sep 27, 1990 | SESE |
| [K864729](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LEQ/K864729.md) | NEUROCHEMICAL ANALYZER | Esa, Inc. | Apr 13, 1987 | SESE |
| [K801439](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LEQ/K801439.md) | MODEL 5100 ELECTROCHEMICAL DETECTOR | Environmental Sciences Assoc., Inc. | Jul 21, 1980 | SESE |

## Top Applicants

- Esa, Inc. — 2 clearances
- Waters Corporation — 1 clearance
- Environmental Sciences Assoc., Inc. — 1 clearance

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

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