510(k) Report

Devices descending from K040535

3 later devices reach Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052010HBA1C Linearity SetCone Bioproducts20052—
+2K121534Cone-Trol Hemoglobin A1C Control SetCone Bioproducts20121—
+3K162514Multichem A1cTechnopath Manufacturing20160—