← Product Code [CDO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO) · K923765

# SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)

_Em Diagnostic Systems, Inc. · CDO · Sep 22, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K923765

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [CDO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO.md)
- **Decision Date:** Sep 22, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1775
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K923765](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K923765)

**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