DIY · Gas Chromatography, Ethosuximide
Clinical Toxicology · 21 CFR 862.3380 · Class 2
Overview
| Product Code | DIY |
|---|---|
| Device Name | Gas Chromatography, Ethosuximide |
| Regulation | 21 CFR 862.3380 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780734 | ANTICONVULSANTS II CALIBRATOR KIT | Vitek Systems, Inc. | Jun 22, 1978 | SESE |
Top Applicants
- Vitek Systems, Inc. — 1 clearance
