Kodak Ektachem Clinical Chemistry Slides

• • Terminated Z-0245-2007 FDA Unclassified (pre-2012) ·initiated 9 Oct 2006

  The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.

510(k) Number

K845027 ↗

FDA Product Code

CHI

Device Class

Class I

Regulation

21 CFR Part 862.1465

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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