Kodak Ektachem Clinical Chemistry Slides (Nail)

• • Terminated Z-3280-2018 FDA Class II ·initiated 5 May 2018

  Potential for positively biased results

• • Terminated Z-1087-2014 FDA Class II ·initiated 17 Oct 2013

  Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

510(k) Number

K924471 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →