← Product Code [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR) · K821931

# ZETA-CORT (K821931)

_Amf Biological and Diagnostics Co. · CGR · Jul 22, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K821931

## Device Facts

- **Applicant:** Amf Biological and Diagnostics Co.
- **Product Code:** [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR.md)
- **Decision Date:** Jul 22, 1982
- **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/CGR/K821931](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K821931)

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