Easy-Test Calcium (Ca), Item No. 67528/93

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K870170 ↗

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 clinical application of the Easy-Test Calcium (Ca) device?

  This device is a Cresolphthalein Complexone reagent designed for the quantitative determination of calcium levels in patient samples within clinical chemistry settings.

• What is the regulatory classification for this calcium measurement device?

  The Easy-Test Calcium (Ca), Item No. 67528/93, is classified as a Class II medical device under regulation number 862.1145 and has received FDA 510(k) clearance under submission number K870170.

• Which advisory committee oversees this clinical chemistry reagent?

  This device falls under the oversight of the Clinical Chemistry advisory committee, identified by the code CH, which monitors diagnostic reagents used for quantitative analysis.