← Product Code [KLB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB) · K813516

# MRI TOBRAMYCIN RIA KIT (K813516)

_Microanalytic Research, Inc. · KLB · Dec 29, 1981 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB/K813516

## Device Facts

- **Applicant:** Microanalytic Research, Inc.
- **Product Code:** [KLB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB.md)
- **Decision Date:** Dec 29, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3900
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

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

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB/K813516](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB/K813516)

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