REAGENT SET, RENORPACE
Device Facts
| Record ID | K770765 |
|---|---|
| Device Name | REAGENT SET, RENORPACE |
| Applicant | G.D. Searle and Co. |
| Product Code | DPA · Clinical Chemistry |
| Decision Date | Jun 24, 1977 |
| 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.
