ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY
Device Facts
| Record ID | K823370 |
|---|---|
| Device Name | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY |
| Applicant | Syva Co. |
| Product Code | KJI · Clinical Toxicology |
| Decision Date | Dec 3, 1982 |
| 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.
