510(k) Report

Devices descending from K993354

1 later device reach K-Assay Apo B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073488Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxDiazyme Laboratories20080—