510(k) Report

Devices descending from K861697

12 later devices reach Self Assure/GHB (Capillary-Blood Collection Kit) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti)19982—
+1K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc.19980—
+1K971919Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc.199711—
+2K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc.200013
+2K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc.1999334
+2K991850Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc.19990—
+2K984529Hemochek Sample Collection KitOsborn Laboratories, Inc.19994—
+2K974491Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp.19981—
+3K141944Home Access Aic TestHome Access Health Corp.20152—
+3K021698MY Allergy TestImmunetech Corporation200206
+4K231465Q-Pad Test SystemQurasense20230—
+4K183230OneDraw A1C Test SystemDrawbridge Health, Inc.20190—