510(k) Report

Devices descending from K022977

2 later devices reach Stratus CS D-Dimer Calpak Calibrator, Model Cddmr-C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063356Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc.200711
+2K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics20080—