← Product Code [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR) · K842365

# CORTI-COTE CORTISOL SOLID PHASE RADIO (K842365)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · CGR · Aug 16, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K842365

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR.md)
- **Decision Date:** Aug 16, 1984
- **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/K842365](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K842365)

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