Kodak Ektachem DT Slides (NBIL)

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

510(k) Number

K921844 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the KODAK EKTACHEM DT SLIDES (NBIL) used for?

  The KODAK EKTACHEM DT SLIDES (NBIL) is used for the quantitative determination of bilirubin in serum or plasma as part of clinical chemistry testing. It is a diazo colorimetry test slide designed specifically for use with the Kodak Ektachem DT analyzer system to measure bilirubin levels in vitro.

• How is the KODAK EKTACHEM DT SLIDES (NBIL) supplied and is it sterile or reusable?

  The device is supplied as a sterile, single-use diagnostic reagent slide. It is intended for one-time use only in laboratory settings and must not be reused, as reusing could compromise test accuracy and pose a risk of contamination.

• What regulatory pathway was used for the KODAK EKTACHEM DT SLIDES (NBIL) and when was it cleared?

  The KODAK EKTACHEM DT SLIDES (NBIL) received FDA 510(k) clearance under submission number K921844 on July 21, 1992. It was found substantially equivalent to a predicate device and is classified as a Class II medical device under product code CIG with special controls.