Calcium Reagent Sys

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K840214 ↗

FDA Product Code

CHZ

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Calcium Reagent System used for?

  The Calcium Reagent System is a Class 2 in vitro diagnostic device used in clinical chemistry laboratories for measuring calcium levels in samples. It contains Di (o-hydroxyphenylimine) Ethane, Calcium as its active component.

• How is the Calcium Reagent System supplied and can it be reused?

  The device is supplied as a reagent system specifically designed for laboratory use. It is intended for single-use applications only and should not be reused or repurposed for multiple tests.

• What are the storage requirements for the Calcium Reagent System?

  The Calcium Reagent System should be stored according to the manufacturer's instructions. It is not MRI compatible, so proper storage conditions must be maintained to ensure the integrity and accuracy of the reagent system.

• What regulatory clearance has the Calcium Reagent System received?

  The Calcium Reagent System received FDA 510(k) clearance with number K840214 on March 19, 1984, under product code CHZ. It was determined to be substantially equivalent to other legally marketed devices.