← Product Code [KXT](/productcode/KXT) · K842655

# EPSILON DIGOXIN TEST KIT (K842655)

_Beckman Instruments, Inc. · KXT · Aug 16, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K842655

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [KXT](/productcode/KXT.md)
- **Decision Date:** Aug 16, 1984
- **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-staging.innolitics.com/device/K842655](https://fda-staging.innolitics.com/device/K842655)

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