← Product Code [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM) · K913187

# INNOFLUOR(TM) DIGITOXIN REAGENT SET (K913187)

_Intl. Bioclinical, Inc. · LFM · Sep 23, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913187

## Device Facts

- **Applicant:** Intl. Bioclinical, Inc.
- **Product Code:** [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM.md)
- **Decision Date:** Sep 23, 1991
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913187](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913187)

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