510(k) Report

Devices descending from K122101

2 later devices reach Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia20170—
+1K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia20141—