← Product Code [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR) · K810941

# AMES TDA TOBRAMYCIN TEST (K810941)

_Miles Laboratories, Inc. · LCR · Apr 17, 1981 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K810941

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR.md)
- **Decision Date:** Apr 17, 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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K810941](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K810941)

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