← Product Code [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ) · K843827

# COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827)

_Roche Diagnostic Systems, Inc. · LCQ · Feb 1, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K843827

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ.md)
- **Decision Date:** Feb 1, 1985
- **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/LCQ/K843827](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K843827)

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