510(k) Report

Devices descending from K103099

6 later devices reach Precicontrol HBA1C Norm; Precicontrol HBA1C Path through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories201443
+1K131999HBA1C Control, Level 1 and Level 2Randox Laboratories, Ltd.20130—
+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