← Product Code [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ) · K840193

# EMIT QST AMIKACIN ASSAY (K840193)

_Syva Co. · KLQ · Mar 23, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K840193

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [KLQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ.md)
- **Decision Date:** Mar 23, 1984
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K840193](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLQ/K840193)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com