← Product Code [LDO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDO) · K841556

# HEART - AID ALS, 95 (K841556)

_Cardiac Resucitator Corp. · LDO · Jul 19, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDO/K841556

## Device Facts

- **Applicant:** Cardiac Resucitator Corp.
- **Product Code:** [LDO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDO.md)
- **Decision Date:** Jul 19, 1984
- **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/LDO/K841556](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDO/K841556)

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