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) → DII — Columns, Glc

# DII · Columns, Glc

_Clinical Chemistry · 21 CFR 862.2250 · Class 1_

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

## Overview

- **Product Code:** DII
- **Device Name:** Columns, 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K874824](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K874824.md) | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | Jan 21, 1988 | SESE |
| [K862542](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K862542.md) | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | Aug 4, 1986 | SESE |
| [K844164](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K844164.md) | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | Lkb Instruments, Inc. | Dec 10, 1984 | SESE |
| [K841712](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K841712.md) | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | Supelco, Inc. | May 21, 1984 | SESE |
| [K791893](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K791893.md) | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | Hewlett-Packard Co. | Oct 30, 1979 | SESE |

## Top Applicants

- Supelco, Inc. — 3 clearances
- Lkb Instruments, Inc. — 1 clearance
- Hewlett-Packard Co. — 1 clearance

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

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