510(k) Report

Devices descending from K001993

8 later devices reach Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.20017—
+2K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+2K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070—
+2K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.200211
+2K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022—
+3K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.20170—
+3K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+4K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—