EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
Device Facts
| Record ID | K881607 |
|---|---|
| Device Name | EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | DLF · Clinical Toxicology |
| Decision Date | Jun 1, 1988 |
| 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.
