← Product Code [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR) · K943313

# PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)

_Sigma Diagnostics, Inc. · LGR · Oct 27, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K943313

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR.md)
- **Decision Date:** Oct 27, 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/K943313](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K943313)

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