510(k) Report

Devices descending from K020210

3 later devices reach Glucometer Dex Blood Glucose System (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023584Ascensia Dex 2 Diabetes Care SystemBayer Corp.20022—
+2K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081—
+3K123966Glucose Meter-Check Solution for BayerBionostics, Inc.20130—