← Product Code [DLP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLP) · K770779

# PHENYTOIN RIA KIT (K770779)

_Amersham Corp. · DLP · Jun 17, 1977 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLP/K770779

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [DLP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLP.md)
- **Decision Date:** Jun 17, 1977
- **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/DLP/K770779](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLP/K770779)

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