← Product Code [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR) · K911613

# VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (K911613)

_Exmoor Plastics , Ltd. · LCR · Jun 28, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K911613

## Device Facts

- **Applicant:** Exmoor Plastics , Ltd.
- **Product Code:** [LCR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR.md)
- **Decision Date:** Jun 28, 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/K911613](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCR/K911613)

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