510(k) Report

Devices descending from K934045

2 later devices reach Beckman HDL Cholesterol Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040767Synchron Systems HDL Cholesterol (HDLD) ReagentBeckman Coulter, Inc.20041—
+2K042195Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…Beckman Coulter, Inc.20040—