← Product Code [LES](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES) · K813538

# PHENYTOIN FLUORESCENT IMMUNOASSAY (K813538)

_American Diagnostic Corp. · LES · Dec 31, 1981 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K813538

## Device Facts

- **Applicant:** American Diagnostic Corp.
- **Product Code:** [LES](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES.md)
- **Decision Date:** Dec 31, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3350
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K813538](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K813538)

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