510(k) Report

Devices descending from K972041

3 later devices reach EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc.20021—
+1K011970Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc.20010—
+2K063852Accessa Cholesterol PanelHome Access Health Corp.20070—