Truebalance Blood Glucose System

• • Ongoing Z-2883-2016 FDA Class II ·initiated 28 Jun 2016

  Product gives incorrect low blood glucose levels.

• • Terminated Z-0909-2014 FDA Class II ·initiated 2 Oct 2013

  Manufactured with an incorrect factory set unit of measure.

510(k) Number

K090495 ↗

FDA Product Code

NBW

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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