← Product Code [LPW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LPW) · K883525

# OXALATE REAGENT (K883525)

_Sigma Chemical Co. · LPW · Oct 25, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LPW/K883525

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [LPW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LPW.md)
- **Decision Date:** Oct 25, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1542
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LPW/K883525](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LPW/K883525)

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