510(k) Report

Devices descending from K063356

1 later device reach Stratus CS Acute Care D-Dimer Testpak, Dilpak, Calpak through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics20080—