← Product Code [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ) · K813541

# AMIKACIN FLUORESCENT IMMUNOASSAY (K813541)

_American Diagnostic Corp. · KLQ · Jan 12, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K813541

## Device Facts

- **Applicant:** American Diagnostic Corp.
- **Product Code:** [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ.md)
- **Decision Date:** Jan 12, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3035
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

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

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K813541](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K813541)

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