510(k) Report

Devices descending from K012324

7 later devices reach Accu-Chek Active Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+1K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070—
+1K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.200211
+1K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022—
+2K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.20170—
+2K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+3K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—