← Product Code [CGL](/productcode/CGL) · K261039

# i-STAT Crea cartridge with the i-STAT 1 System (K261039)

_Abbott Point of Care, Inc. · CGL · Jun 26, 2026 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261039

## Device Facts

- **Applicant:** Abbott Point of Care, Inc.
- **Product Code:** [CGL](/productcode/CGL.md)
- **Decision Date:** Jun 26, 2026
- **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/device/K261039](https://fda.innolitics.com/device/K261039)

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