510(k) Report

Devices descending from K022976

6 later devices reach Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063356Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc.200711
+1K051597Stratus CS D-DimerDade Behring, Inc.200521
+1K040437Triage Profiler S.O.B. PanelBiosite Incorporated20042—
+2K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics20080—
+2K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated20040—
+2K042890Triage D-Dimer Test, Model 98100Biosite Incorporated20040Class I