← Product Code [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP) · K905689

# CEDIA PHENYTOIN ASSAY (K905689)

_Microgenics Corp. · DIP · Jan 17, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K905689

## Device Facts

- **Applicant:** Microgenics Corp.
- **Product Code:** [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP.md)
- **Decision Date:** Jan 17, 1991
- **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/DIP/K905689](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K905689)

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