← Product Code [CEJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ) · K880339

# EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339)

_Em Diagnostic Systems, Inc. · CEJ · Feb 25, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ/K880339

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [CEJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ.md)
- **Decision Date:** Feb 25, 1988
- **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/CEJ/K880339](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ/K880339)

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