510(k) Report

Devices descending from K021484

4 later devices reach Hemoglobin A1C Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…Sebia20122—
+1K050100RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ AnalyzerBionostics, Inc.20050—
+2K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia20170—
+2K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia20141—