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) → DLG — Coating, Liquid, Glc

# DLG · Coating, Liquid, Glc

_Clinical Chemistry · 21 CFR 862.2250 · Class 1_

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

## Overview

- **Product Code:** DLG
- **Device Name:** Coating, Liquid, 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050988](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K050988.md) | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Apr 6, 2006 | SESE |
| [K920419](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K920419.md) | IL TEST DAT CAL/CONTROL SET D/E | Instrumentation Laboratory CO | Mar 11, 1992 | SESE |
| [K894524](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894524.md) | FPR GENTAMICIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE |
| [K894518](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894518.md) | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE |
| [K894528](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894528.md) | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 25, 1989 | SESE |
| [K882766](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K882766.md) | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Em Diagnostic Systems, Inc. | Aug 23, 1988 | SESE |
| [K833385](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K833385.md) | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Dec 16, 1983 | SESE |

## Top Applicants

- Colony Laboratories, Inc. — 3 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Lin-Zhi International, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com