← Product Code [CGL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGL) · K903034

# RENALYZER PRX 90 (K903034)

_Swedish Trade Council USA · CGL · Mar 13, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGL/K903034

## Device Facts

- **Applicant:** Swedish Trade Council USA
- **Product Code:** [CGL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGL.md)
- **Decision Date:** Mar 13, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1225
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGL/K903034](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGL/K903034)

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