← Product Code [DOG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOG) · K760709

# EMIT DIGOKIN ASSAY (K760709)

_Syva Co. · DOG · Oct 21, 1976 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOG/K760709

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [DOG](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOG.md)
- **Decision Date:** Oct 21, 1976
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOG/K760709](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOG/K760709)

**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