Kodak Ektachem Dt Slides (Ca)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K870035 ↗

FDA Product Code

CID

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the primary clinical application for the Kodak Ektachem DT Slides (Ca)?

  These slides are specifically intended for the quantitative measurement of calcium within clinical specimens, providing laboratory professionals with a standardized method for assessing calcium levels.

• How is this device classified for regulatory purposes?

  The Kodak Ektachem DT Slides (Ca) are classified as a Class II medical device under regulation number 862.1145, which pertains to Alizarin Sulfonate, Calcium clinical chemistry devices.

• What is the regulatory status of this device?

  This device has received FDA 510(k) clearance under the number K870035, confirming it has been determined to be substantially equivalent to legally marketed predicate devices.