← Product Code [KLB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB) · K003341

# EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341)

_Syva Co., Dade Behring, Inc. · KLB · Jan 22, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB/K003341

## Device Facts

- **Applicant:** Syva Co., Dade Behring, Inc.
- **Product Code:** [KLB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB.md)
- **Decision Date:** Jan 22, 2001
- **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/KLB/K003341](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLB/K003341)

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