510(k) Report

Devices descending from K022171

3 later devices reach Accu-Chek Compact System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+2K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+3K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—