Dimension Vista Chemistry 3 Calibrator, Model KC130

• • Terminated Z-1535-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009

  patient results are depressed

510(k) Number

K062334 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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