← Product Code [DJB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB) · K760068

# KIT, RIA, GENTAMICIN SULF. (K760068)

_New England Nuclear · DJB · Jul 20, 1976 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB/K760068

## Device Facts

- **Applicant:** New England Nuclear
- **Product Code:** [DJB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB.md)
- **Decision Date:** Jul 20, 1976
- **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/DJB/K760068](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB/K760068)

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