Amresco Na/K Reagent Set

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

510(k) Number

K832070 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Amresco Na/K Reagent Set used for?

  The Amresco Na/K Reagent Set is designed specifically for measuring sodium (Na) and potassium (K) ion concentrations in clinical chemistry. It works in conjunction with compatible ion-selective electrodes to provide accurate readings of these electrolytes in serum or plasma samples, supporting diagnostic assessments in laboratory settings.

• How is the Amresco Na/K Reagent Set supplied, and is it sterile?

  The Amresco Na/K Reagent Set is supplied as a non-sterile, single-use reagent kit. It is intended for in vitro diagnostic use only, meaning it is meant to be used once per sample analysis and then discarded. The non-sterile designation means it is not intended for procedures requiring sterile conditions.

• Is the Amresco Na/K Reagent Set reusable, or is it intended for single-use?

  The Amresco Na/K Reagent Set is explicitly designed for single-use only. This ensures consistency and accuracy in electrolyte measurements, as reuse could introduce variability or contamination, compromising the reliability of test results.

• What storage conditions should be followed for the Amresco Na/K Reagent Set?

  While specific storage conditions are not detailed in the regulatory data, standard laboratory practices should be followed to maintain the integrity of the reagent set. This typically includes storing it in a clean, dry environment away from direct sunlight, extreme temperatures, and chemical fumes. Always refer to the manufacturer’s instructions for precise guidance.

• What regulatory pathway does the Amresco Na/K Reagent Set follow?

  The Amresco Na/K Reagent Set has received FDA 510(k) clearance under the Clinical Chemistry advisory committee, classified as a Class II device. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets applicable regulatory standards for safety and effectiveness in clinical chemistry applications.