← Product Code [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ) · K852158

# BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (K852158)

_Bioprobe Intl., Inc. · LCQ · Jun 25, 1985 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K852158

## Device Facts

- **Applicant:** Bioprobe Intl., Inc.
- **Product Code:** [LCQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ.md)
- **Decision Date:** Jun 25, 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/K852158](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCQ/K852158)

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