← Product Code [DLF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF) · K850174

# TDX ETHOSUXIMIDE (K850174)

_Abbott Laboratories · DLF · Feb 6, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K850174

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [DLF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF.md)
- **Decision Date:** Feb 6, 1985
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K850174](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLF/K850174)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com