← Product Code [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK) · K871902

# THE URIC ACID REAGENT SET (K871902)

_Macomb Biotechnology, Inc. · KNK · Jun 3, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K871902

## Device Facts

- **Applicant:** Macomb Biotechnology, Inc.
- **Product Code:** [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK.md)
- **Decision Date:** Jun 3, 1987
- **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/K871902](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K871902)

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