Kodak Ektachem Clinical Chemistry Slides (Uric)

• • Terminated Z-0092-2017 FDA Class II ·initiated 11 Aug 2016

  Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.

510(k) Number

K932728 ↗

FDA Product Code

KNK

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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