Eukare

• • Terminated Z-0134-2008 FDA Unclassified (pre-2012) ·initiated 14 Aug 2007 ·via K062892, on the same 510(k)

  Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K062892 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Eusure Blood Glucose Monitoring System

  Class II

  FDA 510(k) K040678 Active Cleared 14 Jul 2004