← Product Code [CDH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDH) · K772082

# ENZAC URIC ACID 100-TEST KIT (K772082)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · CDH · Nov 28, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDH/K772082

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [CDH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDH.md)
- **Decision Date:** Nov 28, 1977
- **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/CDH/K772082](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDH/K772082)

**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