← Product Code [LAN](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN) · K922915

# EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (K922915)

_Syva Co. · LAN · Aug 24, 1992 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN/K922915

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [LAN](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN.md)
- **Decision Date:** Aug 24, 1992
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN/K922915](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAN/K922915)

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