510(k) Report

Devices descending from K973365

3 later devices reach Aic - Chek (Hbaic-I) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti)19982—
+2K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc.200013
+3K021698MY Allergy TestImmunetech Corporation200206