← Product Code [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM) · K913240

# DIGITOXIN (FPIA) KIT (K913240)

_Tudor Laboratories, Inc. · LFM · Sep 6, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913240

## Device Facts

- **Applicant:** Tudor Laboratories, Inc.
- **Product Code:** [LFM](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM.md)
- **Decision Date:** Sep 6, 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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913240](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913240)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com