← Product Code [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK) · K970560

# URIC ACID (LIQUID) REAGENT SET (K970560)

_Pointe Scientific, Inc., · KNK · Mar 11, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K970560

## Device Facts

- **Applicant:** Pointe Scientific, Inc.,
- **Product Code:** [KNK](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK.md)
- **Decision Date:** Mar 11, 1997
- **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/K970560](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KNK/K970560)

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