← Product Code [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP) · K770854

# LUTEINIZING HORMONE RIA REAGENT, LH-RIA (K770854)

_Nichols Institute Diagnostics · CEP · May 26, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K770854

## Device Facts

- **Applicant:** Nichols Institute Diagnostics
- **Product Code:** [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP.md)
- **Decision Date:** May 26, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1485
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K770854](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K770854)

**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