EMIT 2000 GENTAMICIN PLUS ASSAY
Device Facts
| Record ID | K010984 |
|---|---|
| Device Name | EMIT 2000 GENTAMICIN PLUS ASSAY |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | LCD · Clinical Toxicology |
| Decision Date | Apr 20, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
