← Product Code [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK) · K924129

# MILES AUTO METH DETERMIN OF URIC ACID IN URINE (K924129)

_Heraeus Kulzer, Inc. · KNK · Sep 22, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K924129

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK.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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K924129](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K924129)

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