← Product Code [DKD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKD) · K780951

# BIO-MONITOR GENTAMICIN (K780951)

_Monitor Science Corp. · DKD · Aug 14, 1978 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKD/K780951

## Device Facts

- **Applicant:** Monitor Science Corp.
- **Product Code:** [DKD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKD.md)
- **Decision Date:** Aug 14, 1978
- **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/DKD/K780951](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKD/K780951)

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