510(k) Report

Devices descending from K851636

5 later devices reach Diamat Glycoslated Hemoglobin Analyzer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992085Abbott Imx Glycated Hemoglobin IIAbbott Laboratories20000—
+1K991483Abbott Architect Glycated HemoglobinAbbott Laboratories19990—
+1K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti)19982—
+2K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc.200013
+3K021698MY Allergy TestImmunetech Corporation200206