← Product Code [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ) · K820781

# COAT-A-COUNT AMIKACIN IRA (K820781)

_Diagnostic Products Corp. · KLQ · Apr 9, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K820781

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ.md)
- **Decision Date:** Apr 9, 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/K820781](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K820781)

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