← Product Code [DPB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPB) · K790540

# RIA TEST KIT, CENTRIA DIGOXIN (K790540)

_Ventrex Laboratories, Inc. · DPB · Apr 23, 1979 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPB/K790540

## Device Facts

- **Applicant:** Ventrex Laboratories, Inc.
- **Product Code:** [DPB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPB.md)
- **Decision Date:** Apr 23, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3320
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

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

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPB/K790540](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPB/K790540)

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