← Product Code [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ) · K894523

# FPR GENTAMICIN KIT (K894523)

_Colony Laboratories, Inc. · LCQ · Sep 28, 1989 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K894523

## Device Facts

- **Applicant:** Colony Laboratories, Inc.
- **Product Code:** [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ.md)
- **Decision Date:** Sep 28, 1989
- **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/K894523](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K894523)

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