510(k) Report

Devices descending from K062347

3 later devices reach Ascensia Breeze 2 Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+1K080273AB-Trol and Private Label Glucose Control SolutionFujirebio Diagnostics Texas, Inc.20080—
+2K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—