← Product Code [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI) · K822808

# TDX KENAMYCIN (K822808)

_Abbott Laboratories · KJI · Oct 8, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K822808

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI.md)
- **Decision Date:** Oct 8, 1982
- **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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K822808](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K822808)

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