Kodak Ektachem Clinical Chemistry Slides (Li)

• • Terminated Z-1471-2017 FDA Class II ·initiated 1 Feb 2017

  Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.

• • Terminated Z-0316-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

510(k) Number

K924488 ↗

FDA Product Code

JIH

Device Class

Class II

Regulation

21 CFR Part 862.3560

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What are Kodak Ektachem Clinical Chemistry Slides (Li) used for?

  These slides are medical devices designed for flame photometry to measure lithium levels in clinical laboratory settings. They are intended for clinical toxicology applications and provide accurate lithium testing results when used with the Ektachem clinical chemistry system.

• How are the Kodak Ektachem Clinical Chemistry Slides (Li) supplied?

  The slides are supplied as single-use devices and are not MRI safe. They are designed for one-time use only and should be stored according to manufacturer specifications to maintain their integrity and accuracy.

• What is the regulatory status of the Kodak Ektachem Clinical Chemistry Slides (Li)?

  The device is authorized under FDA 510(k) clearance with product code JIH. It is classified as Class II and received a decision code of SESE (Substantially Equivalent) on January 26, 1993, after being submitted on September 3, 1992.

• What sizes and models of Kodak Ektachem Clinical Chemistry Slides (Li) are available?

  The device data does not specify multiple sizes or models for the Kodak Ektachem Clinical Chemistry Slides (Li). The information provided indicates a single product designed specifically for lithium measurement using flame photometry technology.