EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
Device Facts
| Record ID | K010812 |
|---|---|
| Device Name | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | LAR · Clinical Toxicology |
| Decision Date | Apr 13, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
