← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K840887

# AMRESCO E2A REAGENT SET 0562 & 0626 (K840887)

_American Research Products Co. · CEM · Apr 18, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K840887

## Device Facts

- **Applicant:** American Research Products Co.
- **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md)
- **Decision Date:** Apr 18, 1984
- **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/K840887](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K840887)

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