510(k) Report

Devices descending from K984529

4 later devices reach Hemochek Sample Collection Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc.1999334
+2K141944Home Access Aic TestHome Access Health Corp.20152—
+3K231465Q-Pad Test SystemQurasense20230—
+3K183230OneDraw A1C Test SystemDrawbridge Health, Inc.20190—