← Product Code [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR) · K935375

# AXSYM PHENYTOIN ASSAY (K935375)

_Abbott Laboratories · LGR · Jun 21, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K935375

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR.md)
- **Decision Date:** Jun 21, 1994
- **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/LGR/K935375](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K935375)

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