← Product Code [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM) · K830035

# SOPHEIA DIGITOXIN EIA KIT & COMPONENTS (K830035)

_Diagnostic Products Corp. · LFM · Jan 28, 1983 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K830035

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM.md)
- **Decision Date:** Jan 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3300
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K830035](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K830035)

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