← Product Code [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM) · K842786

# DYNA-LYTE 2000 (K842786)

_Abbott Diagnostics · CEM · Sep 14, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K842786

## Device Facts

- **Applicant:** Abbott Diagnostics
- **Product Code:** [CEM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM.md)
- **Decision Date:** Sep 14, 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/K842786](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEM/K842786)

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