510(k) Report

Devices descending from K022180

2 later devices reach Direct Bilirubin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…Medicon Hellas S.A20211—
+2K251157Core MetabolicTruvian Health20260—