← Product Code [LCD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD) · K900703

# MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (K900703)

_Innotron of Oregon, Inc. · LCD · Apr 12, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K900703

## Device Facts

- **Applicant:** Innotron of Oregon, Inc.
- **Product Code:** [LCD](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD.md)
- **Decision Date:** Apr 12, 1990
- **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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K900703](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCD/K900703)

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