← Product Code [LCD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD) · K893912

# TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD (K893912)

_Technicon Instruments Corp. · LCD · Aug 21, 1989 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K893912

## Device Facts

- **Applicant:** Technicon Instruments Corp.
- **Product Code:** [LCD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD.md)
- **Decision Date:** Aug 21, 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/LCD/K893912](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K893912)

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