MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
Device Facts
| Record ID | K900707 |
|---|---|
| Device Name | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR |
| Applicant | Innotron of Oregon, Inc. |
| Product Code | LFW · Clinical Toxicology |
| Decision Date | Apr 20, 1990 |
| 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.
