← Product Code [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR) · K911940

# OPUS(R) TOBRAMYCIN (K911940)

_Pb Diagnostic Systems, Inc. · LCR · Jul 1, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K911940

## Device Facts

- **Applicant:** Pb Diagnostic Systems, Inc.
- **Product Code:** [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR.md)
- **Decision Date:** Jul 1, 1991
- **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/K911940](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K911940)

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