EMIT NETILMICIN ASSAY
Device Facts
| Record ID | K833715 |
|---|---|
| Device Name | EMIT NETILMICIN ASSAY |
| Applicant | Syva Co. |
| Product Code | LCE · Clinical Toxicology |
| Decision Date | Dec 27, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
