← Product Code [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR) · K840466

# NML CORTISOL RIA (K840466)

_Nuclear Medical Laboratories, Inc. · CGR · Mar 30, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K840466

## Device Facts

- **Applicant:** Nuclear Medical Laboratories, Inc.
- **Product Code:** [CGR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR.md)
- **Decision Date:** Mar 30, 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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K840466](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGR/K840466)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com