← Product Code [DKG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DKG) · K894327

# EMIT D.A.U. LOW & MEDIUM CALIBRATOR A (K894327)

_Syva Co. · DKG · Aug 3, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DKG/K894327

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DKG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DKG.md)
- **Decision Date:** Aug 3, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2270
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DKG/K894327](https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DKG/K894327)

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