REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
Device Facts
| Record ID | K844164 |
|---|---|
| Device Name | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A |
| Applicant | Lkb Instruments, Inc. |
| Product Code | DII · Clinical Chemistry |
| Decision Date | Dec 10, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2250 |
| Device Class | Class 1 |
Regulatory Classification
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.