510(k) Report

Devices descending from K110188

1 later device reach Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133803Diazyme Glycated Serum Protein Poc Test KitDiazyme Laboratories20140—