510(k) Report

Devices descending from K003419

2 later devices reach RCRP Flex Reagent Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.202312
+2K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH20230—