ANALYZER, FAST, CENTRIFUGAL, GEMSAEC
Device Facts
| Record ID | K780380 |
|---|---|
| Device Name | ANALYZER, FAST, CENTRIFUGAL, GEMSAEC |
| Applicant | Syva Co. |
| Product Code | DLF · Clinical Toxicology |
| Decision Date | Apr 12, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3380 |
| Device Class | Class 2 |
Regulatory Classification
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.
