Dimension Vista Chemistry 2 Calibrator (Chem 2 Cal, KC120)

• • Terminated Z-2387-2010 FDA Unclassified (pre-2012) ·initiated 26 Feb 2010

  There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.

510(k) Number

K061703 ↗

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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