Accu-Chek(R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage H Test Strips

• 2 recalls, same reason

  • Terminated Z-1364-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006
  • Terminated Z-1363-06 FDA Unclassified (pre-2012) ·initiated 22 Jun 2006

  The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.

510(k) Number

K973662 ↗

FDA Product Code

LFR

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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