← Product Code [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX) · K902172

# COULTER CREATININE REAGENT (K902172)

_Coulter Corp. · CGX · Jun 28, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K902172

## Device Facts

- **Applicant:** Coulter Corp.
- **Product Code:** [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX.md)
- **Decision Date:** Jun 28, 1990
- **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/CGX/K902172](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K902172)

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