510(k) Report

Devices descending from K010597

2 later devices reach Synchron LX Systems High Sensitivity C-Reactive Protien (CRPH) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070626Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentBeckman Coulter, Inc.20071—
+2K091052Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc.20100—