← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K915345

# STAT K SYSTEM (K915345)

_Portable Diagnostic Services, Inc. · CEM · Jul 16, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K915345

## Device Facts

- **Applicant:** Portable Diagnostic Services, Inc.
- **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md)
- **Decision Date:** Jul 16, 1992
- **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/K915345](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K915345)

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