Kodak Ektachem Dt 60 Analyzer

• • Terminated Z-0151-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006 ·on shared 510(k) K841503

  Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

• • Terminated Z-1225-03 FDA Unclassified (pre-2012) ·initiated 28 Jul 2003 ·on shared 510(k) K841503

  Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K841503 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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