Kodak Ektachem Clin. Chem. Slides (Trig)

• • Terminated Z-0848-2015 FDA Class II ·initiated 6 Nov 2014

  Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

510(k) Number

K812029 ↗

FDA Product Code

CDT

Device Class

Class I

Regulation

21 CFR Part 862.1705

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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