← Product Code [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI) · K823370

# ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370)

_Syva Co. · KJI · Dec 3, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K823370

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [KJI](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI.md)
- **Decision Date:** Dec 3, 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/K823370](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KJI/K823370)

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