EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
Device Facts
| Record ID | K894327 |
|---|---|
| Device Name | EMIT D.A.U. LOW & MEDIUM CALIBRATOR A |
| Applicant | Syva Co. |
| Product Code | DKG · Clinical Chemistry |
| Decision Date | Aug 3, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2270 |
| Device Class | Class 1 |
Regulatory Classification
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.
