Trackease Smart System Blood Glucose System

• • Ongoing Z-2882-2016 FDA Class II ·initiated 28 Jun 2016 ·on shared 510(k) K042080

  Product gives incorrect low blood glucose levels.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K042080 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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