← Product Code [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ) · K822657

# EMIT-AMD AMIKACIN ASSAY (K822657)

_Dade Behring, Inc. · KLQ · Sep 28, 1982 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K822657

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ.md)
- **Decision Date:** Sep 28, 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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K822657](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K822657)

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