510(k) Report

Devices descending from K004010

4 later devices reach Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022171Accu-Chek Compact SystemRoche Diagnostics Corp.200232
+2K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+3K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+4K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—