← Product Code [LES](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES) · K831154

# STRATUS PHENYTOIN FLUOROMETRIC ENZYME (K831154)

_American Dade · LES · May 16, 1983 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K831154

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [LES](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES.md)
- **Decision Date:** May 16, 1983
- **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/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K831154](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K831154)

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