STRATUS GENTAMICIN FLUOROMETRIC ENZYM
Device Facts
| Record ID | K832445 |
|---|---|
| Device Name | STRATUS GENTAMICIN FLUOROMETRIC ENZYM |
| Applicant | American Dade |
| Product Code | LCD · Clinical Toxicology |
| Decision Date | Aug 31, 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.
