← Product Code [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI) · K832769

# AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769)

_Miles Laboratories, Inc. · KJI · Sep 29, 1983 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K832769

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI.md)
- **Decision Date:** Sep 29, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3520
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K832769](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K832769)

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