EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
Device Facts
| Record ID | K003341 |
|---|---|
| Device Name | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | KLB · Clinical Toxicology |
| Decision Date | Jan 22, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
