← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K010061

# DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND (K010061)

_Dade Behring, Inc. · CEM · Mar 14, 2001 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K010061

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md)
- **Decision Date:** Mar 14, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1600
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K010061](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K010061)

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