Paramax Electrolyte Calibrator

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

510(k) Number

K863489 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Paramax Electrolyte Calibrator used for?

  The Paramax Electrolyte Calibrator is a multi-analyte mixture designed to provide standardized reference values for calibrating laboratory instruments that measure electrolyte levels in patient samples in clinical chemistry laboratories.

• How is the Paramax Electrolyte Calibrator supplied?

  The device is supplied as a Class II medical device with special controls under product code JIX. It is manufactured by American Dade and is used specifically for calibrating electrolyte testing equipment.

• What is the regulatory status of the Paramax Electrolyte Calibrator?

  The Paramax Electrolyte Calibrator is authorized by the FDA with 510(k) clearance K863489. It is classified as a Class II medical device with special controls and is intended for use in clinical chemistry laboratories.

• Is the Paramax Electrolyte Calibrator single-use or reusable?

  The device information does not specify whether the Paramax Electrolyte Calibrator is designed for single-use or multiple uses. The description indicates it is a calibrator mixture used for reference values, but does not detail its usage limitations.