← Product Code [LNW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LNW) · K850858

# OB-PH - PH TEST PAPER (K850858)

_Uro Pharmaceuticals, Inc. · LNW · May 24, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LNW/K850858

## Device Facts

- **Applicant:** Uro Pharmaceuticals, Inc.
- **Product Code:** [LNW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LNW.md)
- **Decision Date:** May 24, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1550
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LNW/K850858](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LNW/K850858)

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