← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K833776

# QEA SODIUM/POTASSIUM ANALYZER (K833776)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · CEM · Dec 29, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K833776

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md)
- **Decision Date:** Dec 29, 1983
- **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/K833776](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K833776)

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