← Product Code [DJB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB) · K811844

# COAT-A-COUNT GENTAMICIN RIA KIT (K811844)

_Diagnostic Products Corp. · DJB · Jul 10, 1981 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB/K811844

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [DJB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB.md)
- **Decision Date:** Jul 10, 1981
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB/K811844](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DJB/K811844)

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