COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
Device Facts
| Record ID | K871484 |
|---|---|
| Device Name | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LGS · Clinical Toxicology |
| Decision Date | May 28, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
