← Product Code [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI) · K792189

# NORDICLAB TOTAL ESTRIOL RIA TEST (K792189)

_Nordiclab Intl. · CGI · Nov 13, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K792189

## Device Facts

- **Applicant:** Nordiclab Intl.
- **Product Code:** [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI.md)
- **Decision Date:** Nov 13, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1265
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K792189](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K792189)

**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