Accu-Chek Comfort Curve Test Strip

• • Terminated Z-0715-03 FDA Unclassified (pre-2012) ·initiated 12 Feb 2003

  Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

510(k) Number

K982002 ↗

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. →