COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
Device Facts
| Record ID | K852320 |
|---|---|
| Device Name | COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LAR · Clinical Toxicology |
| Decision Date | Jul 9, 1985 |
| 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.
