← Product Code [LCS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCS) · K864802

# DART DIGOXIN ASSAY (K864802)

_Coulter Electronics, Inc. · LCS · Feb 12, 1987 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LCS/K864802

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [LCS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCS.md)
- **Decision Date:** Feb 12, 1987
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LCS/K864802](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LCS/K864802)

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