TOBRAMYCIN ANALYTICAL TEST PACK-ACA
Device Facts
| Record ID | K832985 |
|---|---|
| Device Name | TOBRAMYCIN ANALYTICAL TEST PACK-ACA |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | KLB · Clinical Toxicology |
| Decision Date | Oct 27, 1983 |
| 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.
