Glucose Control Solution for Therasense Freestyle

• • Terminated Z-0605-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006

  The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

510(k) Number

K013147 ↗

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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