← Product Code [JFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT) · K931031

# VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031)

_Biomerieux Vitek, Inc. · JFT · Jul 27, 1993 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K931031

## Device Facts

- **Applicant:** Biomerieux Vitek, Inc.
- **Product Code:** [JFT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT.md)
- **Decision Date:** Jul 27, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1205
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K931031](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFT/K931031)

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