510(k) Report

Devices descending from K962523

7 later devices reach N Latex CRP Mono Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990825Revised C-Reactive Protein (RCRP) Flex Reagent CartridgeDade Behring, Inc.19990—
+1K981638Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc.199841
+1K964687N Latex CRP Mono ReagentBehring Diagnostics, Inc.19960—
+2K050836CRP Diagnostic AssaySentinel Ch. Srl20051—
+2K022690Paros CRPHoriba, Ltd.20020—
+2K990704Array 360 System C-Reactive Protein (CRP Mpe) ReagentBeckman Coulter, Inc.19990—
+3K192118CRP VarioSENTINEL CH. SpA20190—