Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2250](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2250) → DMS — Gases, Glc

# DMS · Gases, Glc

_Clinical Chemistry · 21 CFR 862.2250 · Class 1_

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

## Overview

- **Product Code:** DMS
- **Device Name:** Gases, Glc
- **Regulation:** [21 CFR 862.2250](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2250)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

## 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 (0 of 0)

_No cleared devices on record._

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

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