← Product Code [LEH](/productcode/LEH) · K940595

# AXSYM VANCOMYCIN (K940595)

_Abbott Laboratories · LEH · Jun 21, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K940595

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [LEH](/productcode/LEH.md)
- **Decision Date:** Jun 21, 1994
- **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-staging.innolitics.com/device/K940595](https://fda-staging.innolitics.com/device/K940595)

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