LCY · U.V. Spectrometry, Theophylline
Clinical Toxicology · 21 CFR 862.3880 · Class 2
Overview
| Product Code | LCY |
|---|---|
| Device Name | U.V. Spectrometry, Theophylline |
| Regulation | 21 CFR 862.3880 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891761 | GDS ENZYMATIC THEOPHYLLINE REAGENT | Gds Diagnostics | May 16, 1989 | SESE |
| K780442 | THEOPHYLLINE ASSAY TO THE GEMSAEC | Syva Co. | Apr 12, 1978 | SESE |
| K780441 | THEOPHYLLINE ASSAY TO THE CENTRIFICHEM | Syva Co. | Apr 12, 1978 | SESE |
Top Applicants
- Syva Co. — 2 clearances
- Gds Diagnostics — 1 clearance
