Iq Calcium

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

510(k) Number

K891217 ↗

FDA Product Code

CIC

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 primary function of the IQ Calcium system?

  The IQ Calcium system is a clinical chemistry test system that utilizes cresolphthalein complexone to facilitate the measurement of calcium levels in clinical samples.

• How is the IQ Calcium device classified for regulatory purposes?

  This device is classified as a Class 2 medical device under regulation number 862.1145. It has received FDA 510(k) clearance through the traditional pathway, confirming it is substantially equivalent to predicate devices.

• Which medical specialty is this device intended for?

  The IQ Calcium system is intended for use within the clinical chemistry specialty, as indicated by its classification under the clinical chemistry advisory committee.