← Product Code [DII](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII) · K844164

# REACTIFS, IBF ULTROGELS ACA & ULTROGELS A (K844164)

_Lkb Instruments, Inc. · DII · Dec 10, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K844164

## Device Facts

- **Applicant:** Lkb Instruments, Inc.
- **Product Code:** [DII](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII.md)
- **Decision Date:** Dec 10, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2250
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K844164](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DII/K844164)

**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
