510(k) Report

Devices descending from K981638

4 later devices reach Immage Immunochemistry System C-Reactive Protein (CRP) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050836CRP Diagnostic AssaySentinel Ch. Srl20051—
+1K022690Paros CRPHoriba, Ltd.20020—
+1K990704Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc.19990—
+2K192118CRP VarioSENTINEL CH. SpA20190—