← Product Code [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH) · K881040

# EMIT VANCOMYCIN ASSAY (K881040)

_Syva Co. · LEH · Apr 19, 1988 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K881040

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH.md)
- **Decision Date:** Apr 19, 1988
- **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/K881040](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K881040)

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