AMES TDA KANAMYCIN TEST-CONTROL SERUM
Device Facts
| Record ID | K832769 |
|---|---|
| Device Name | AMES TDA KANAMYCIN TEST-CONTROL SERUM |
| Applicant | Miles Laboratories, Inc. |
| Product Code | KJI · Clinical Toxicology |
| Decision Date | Sep 29, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3520 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.
