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) → KZQ — Chromatography(Gas), Clinical Use

# KZQ · Chromatography(Gas), Clinical Use

_Clinical Chemistry · 21 CFR 862.2250 · Class 1_

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

## Overview

- **Product Code:** KZQ
- **Device Name:** Chromatography(Gas), Clinical Use
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K872122](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K872122.md) | 8000 SERIES GAS CHROMATOGRAPHS | The Perkin-Elmer Corp. | Jun 17, 1987 | SESE |
| [K841891](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K841891.md) | VARIAN 3300 & 3400 GAS CHROMATOGRAPHS | Varian Assoc., Inc. | Jul 9, 1984 | SESE |
| [K832962](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K832962.md) | GAS CHROMATOGRAPH 5890A | Hewlett-Packard Co. | Oct 28, 1983 | SESE |
| [K831387](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K831387.md) | HS-100 HEADSPACE SAMPLING ACCESSORY | The Perkin-Elmer Corp. | Aug 24, 1983 | SESE |
| [K830147](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K830147.md) | SIGMA 300 GAS CHROMATROGRAPH | The Perkin-Elmer Corp. | Feb 7, 1983 | SESE |
| [K820283](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K820283.md) | SIGMA 2000 GAS CHROMATOGRAPH | The Perkin-Elmer Corp. | Feb 23, 1982 | SESE |
| [K820025](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K820025.md) | TRACE ANALYTICAL REDUCTION GAS ANALYZ | Trace Analytical | Feb 15, 1982 | SESE |
| [K820071](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K820071.md) | MODEL 5790 GAS CHROMATOGRAPH | Hewlett-Packard Co. | Jan 28, 1982 | SESE |
| [K801745](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K801745.md) | VISTA 44 GAS CHROMATOGRAPHY ANALYSIS | Varian Assoc., Inc. | Aug 20, 1980 | SESE |
| [K791138](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K791138.md) | 5880 SERIES OF GAS CHROMATOGRAPHS | Hewlett-Packard Co. | Jul 24, 1979 | SESE |
| [K770639](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K770639.md) | DETECTOR, IR, MODEL GC-33 | Peokin-Elmer Corp. | Jun 24, 1977 | SESE |
| [K770025](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZQ/K770025.md) | GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 | The Perkin-Elmer Corp. | Feb 16, 1977 | SESE |

## Top Applicants

- The Perkin-Elmer Corp. — 5 clearances
- Hewlett-Packard Co. — 3 clearances
- Varian Assoc., Inc. — 2 clearances
- Peokin-Elmer Corp. — 1 clearance
- Trace Analytical — 1 clearance

---

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

**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