510(k) Report

Devices descending from K180074

2 later devices reach Diazyme Lipoprotein (a) Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.20260—
+1K211058Lp (a) UltraSENTINEL CH. SpA20220—