510(k) Report

Devices descending from K990899

3 later devices reach Hemochek-A1C Sample Collection Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141944Home Access Aic TestHome Access Health Corp.20152—
+2K231465Q-Pad Test SystemQurasense20230—
+2K183230OneDraw A1C Test SystemDrawbridge Health, Inc.20190—