← Product Code [LFW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFW) · K944371

# TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (K944371)

_Sigma Diagnostics, Inc. · LFW · Nov 10, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFW/K944371

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [LFW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFW.md)
- **Decision Date:** Nov 10, 1994
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFW/K944371](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LFW/K944371)

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