← Product Code [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH) · K945125

# DUPONT ACA VANCOMYCIN (VANC) METHOD (K945125)

_The DU Pont Co. · LEH · Mar 10, 1995 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K945125

## Device Facts

- **Applicant:** The DU Pont Co.
- **Product Code:** [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH.md)
- **Decision Date:** Mar 10, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3950
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K945125](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K945125)

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