TECHNICON STAR SYSTEM
Device Facts
| Record ID | K791549 |
|---|---|
| Device Name | TECHNICON STAR SYSTEM |
| Applicant | Technicon Instruments Corp. |
| Product Code | DON · Clinical Toxicology |
| Decision Date | Sep 27, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3320 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
