← Product Code [DLG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG) · K894528

# FPR PHENYTOIN CALIBRATOR KIT (K894528)

_Colony Laboratories, Inc. · DLG · Sep 25, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894528

## Device Facts

- **Applicant:** Colony Laboratories, Inc.
- **Product Code:** [DLG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DLG.md)
- **Decision Date:** Sep 25, 1989
- **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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894528](https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DLG/K894528)

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