← Product Code [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH) · K955716

# VANCOMYCIN FPIA REAGENT SET (K955716)

_Sigma Diagnostics, Inc. · LEH · Feb 16, 1996 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K955716

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [LEH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH.md)
- **Decision Date:** Feb 16, 1996
- **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/K955716](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LEH/K955716)

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