510(k) Report

Devices descending from K023763

3 later devices reach Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation20170—
+1K131307Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine CalibratorSiemens Healthcare Diagnostics, Inc.201405
+1K042193Diazyme Glycated Serum Protein Enzymatic Assay KitDiazyme Laboratories20041—