← Product Code [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK) · K831864

# URIC-ACID TEST ENZYMATIC COLORIMETRIC (K831864)

_Stanbio Laboratory · KNK · Jul 22, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K831864

## Device Facts

- **Applicant:** Stanbio Laboratory
- **Product Code:** [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK.md)
- **Decision Date:** Jul 22, 1983
- **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/KNK/K831864](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K831864)

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