← Product Code [DIY](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY) · K780734

# ANTICONVULSANTS II CALIBRATOR KIT (K780734)

_Vitek Systems, Inc. · DIY · Jun 22, 1978 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY/K780734

## Device Facts

- **Applicant:** Vitek Systems, Inc.
- **Product Code:** [DIY](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY.md)
- **Decision Date:** Jun 22, 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/DIY/K780734](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY/K780734)

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