← Product Code [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR) · K895407

# CORTISOL CLASP-BEAD EIA KIT (K895407)

_Biotecx Laboratories, Inc. · CGR · Oct 19, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K895407

## Device Facts

- **Applicant:** Biotecx Laboratories, Inc.
- **Product Code:** [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR.md)
- **Decision Date:** Oct 19, 1989
- **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/K895407](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K895407)

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