510(k) Report

Devices descending from K971919

11 later devices reach Ezchek/Hba Blood Collection Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc.1999334
+1K991850Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc.19990—
+1K984529Hemochek Sample Collection KitOsborn Laboratories, Inc.19994—
+1K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti)19982—
+1K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc.19980—
+1K974491Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp.19981—
+2K141944Home Access Aic TestHome Access Health Corp.20152—
+2K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc.200013
+3K231465Q-Pad Test SystemQurasense20230—
+3K183230OneDraw A1C Test SystemDrawbridge Health, Inc.20190—
+3K021698MY Allergy TestImmunetech Corporation200206