← Product Code [CEJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ) · K861713

# SERUM POTASSIUM REAGENT SET (K861713)

_Sterling Diagnostics, Inc. · CEJ · May 23, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ/K861713

## Device Facts

- **Applicant:** Sterling Diagnostics, Inc.
- **Product Code:** [CEJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ.md)
- **Decision Date:** May 23, 1986
- **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/K861713](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEJ/K861713)

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