Kodak Ektachem Electrolyte Analyzer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K800054 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What types of samples can the Kodak Ektachem Electrolyte Analyzer measure, and where is it typically used?

  The Kodak Ektachem Electrolyte Analyzer is designed for quantitative measurement of electrolyte levels, specifically potassium and other ion concentrations, in clinical chemistry samples. It is intended for use in clinical laboratory settings to assess metabolic and electrolyte balance, helping clinicians monitor patient health through precise biochemical analysis.

• Is the Kodak Ektachem Electrolyte Analyzer a single-use or reusable device, and what are its disposable components?

  The Kodak Ektachem Electrolyte Analyzer itself is a reusable instrument. However, it requires disposable test slides for operation, ensuring each measurement is performed with fresh, sterile components to maintain accuracy and hygiene in clinical settings.

• How was the regulatory pathway for this device determined, and what classification does it hold?

  The Kodak Ektachem Electrolyte Analyzer received FDA clearance through the Traditional 510(k) pathway, specifically under the decision code *SESE* (Substantially Equivalent). It is classified as a Class 2 Chemistry device under product code *CEM*, indicating it is subject to general controls and special controls for chemistry analyzers.

• Are there any special storage requirements for the Kodak Ektachem Electrolyte Analyzer or its consumables?

  The regulatory data does not specify sterility or special storage conditions for the reusable analyzer itself, but since it relies on disposable test slides, those consumables should be stored according to manufacturer guidelines to preserve performance and prevent contamination. Always follow the provided instructions for proper handling and shelf life.