← Product Code [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP) · K792000 # LUTEINIZING HORMONE (LH) RIA (K792000) _Cis Radiopharmaceuticals, Inc. · CEP · Oct 30, 1979 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K792000 ## Device Facts - **Applicant:** Cis Radiopharmaceuticals, Inc. - **Product Code:** [CEP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP.md) - **Decision Date:** Oct 30, 1979 - **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/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K792000](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K792000) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEP/K792000