← Product Code [CDO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO) · K770767

# IN VITRO DIAG. FOR URIC ACID (K770767)

_Smithkline Diagnostics, Inc. · CDO · Jul 5, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K770767

## Device Facts

- **Applicant:** Smithkline Diagnostics, Inc.
- **Product Code:** [CDO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO.md)
- **Decision Date:** Jul 5, 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K770767](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDO/K770767)

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