510(k) Report

Devices descending from K052010

2 later devices reach HBA1C Linearity Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121534Cone-Trol Hemoglobin A1C Control SetCone Bioproducts20121—
+2K162514Multichem A1cTechnopath Manufacturing20160—