← Product Code [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI) · K823062

# KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062)

_American Diagnostic Corp. · KJI · Nov 10, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K823062

## Device Facts

- **Applicant:** American Diagnostic Corp.
- **Product Code:** [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI.md)
- **Decision Date:** Nov 10, 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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K823062](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K823062)

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