← Product Code [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR) · K842455

# AMER. BIO-SCIENCE LAB CORTISOL REAGENT (K842455)

_American Bio-Science Laboratories · CGR · Aug 16, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K842455

## Device Facts

- **Applicant:** American Bio-Science Laboratories
- **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/K842455](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K842455)

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