N-ACETYLPROCAINAMIDE CALIBRATOR
Device Facts
| Record ID | K833385 |
|---|---|
| Device Name | N-ACETYLPROCAINAMIDE CALIBRATOR |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | DLG · Clinical Chemistry |
| Decision Date | Dec 16, 1983 |
| 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.
