Kodak Ektachem Clin. Chem. Slides (Tp)

• • Terminated Z-0919-03 FDA Unclassified (pre-2012) ·initiated 26 Mar 2003

  Slides may exhibit random, elevated imprecision of results.

510(k) Number

K812028 ↗

FDA Product Code

CEK

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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