← Product Code [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ) · K800032

# FIAX TEST KIT FOR GENTAMICIN QUAN. (K800032)

_Intl. Diagnostic Technology · LCQ · Jan 23, 1980 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K800032

## Device Facts

- **Applicant:** Intl. Diagnostic Technology
- **Product Code:** [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ.md)
- **Decision Date:** Jan 23, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3450
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K800032](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K800032)

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