510(k) Report

Devices descending from K081403

2 later devices reach Glucose Meter-Check Control Solution for Roche Accu-Chek through their predicates, nearest generation first.

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