Accu-Chek Hq System

• • Terminated Z-1365-06 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

K983047 ↗

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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See all devices from Boehringer Mannheim Corp. →