510(k) Report

Devices descending from K952720

2 later devices reach Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041635G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd.200414
+2K081269Avie A1C Test SystemMec Dynamics Corp20090—