FPR AMIKACIN CALIBRATOR KIT
Device Facts
| Record ID | K894518 |
|---|---|
| Device Name | FPR AMIKACIN CALIBRATOR KIT |
| Applicant | Colony Laboratories, Inc. |
| Product Code | DLG · Clinical Chemistry |
| Decision Date | Sep 28, 1989 |
| 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.
