510(k) Report

Devices descending from K093626

2 later devices reach Innovance D-Dimer, Model OPBP09 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH20260—
+1K110303Stratus CS Acute Care D-DimerSiemens Healthcare Diagnostics201101