← Product Code [LCD](/productcode/LCD) · K860045

# DETERMINATION OF GENTAMICIN (K860045)

_Clinical Data, Inc. · LCD · Jan 22, 1986 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K860045

## Device Facts

- **Applicant:** Clinical Data, Inc.
- **Product Code:** [LCD](/productcode/LCD.md)
- **Decision Date:** Jan 22, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3450
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

---

**Source:** [https://fda-staging.innolitics.com/device/K860045](https://fda-staging.innolitics.com/device/K860045)

**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