510(k) Report

Devices descending from K052101

6 later devices reach C.F.a.S. (Calibrator for Automated Systems) HBA1C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics201502
+1K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories201443
+2K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc.20180—
+2K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc.201711
+2K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories201502
+3K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.202102