← Product Code [DLF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF) · K780461

# ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 (K780461)

_Syva Co. · DLF · Apr 12, 1978 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K780461

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DLF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF.md)
- **Decision Date:** Apr 12, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3380
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K780461](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K780461)

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