510(k) Report

Devices descending from K130255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc.20180—
+1K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc.201711
+1K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories201502
+2K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.202102