MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
Device Facts
| Record ID | K011166 |
|---|---|
| Device Name | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 |
| Applicant | Syva Co., Dade Behring, Inc. |
| Product Code | KLS · Clinical Toxicology |
| Decision Date | May 10, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
