510(k) Report

Devices descending from K973819

29 later devices reach Vidas D-Dimer (DD) Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022976Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DDade Behring, Inc.200361
+1K020810Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc.200221—
+2K063356Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc.200711
+2K051597Stratus CS D-DimerDade Behring, Inc.200521
+2K040437Triage Profiler S.O.B. PanelBiosite Incorporated20042—
+2K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc.200419—
+2K030328Vidas D-Dimer New (DD2) Assay, Model 30 442bioMerieux, Inc.20030—
+3K162227STA® - Liatest® D-DiDiagnostica Stago201602
+3K141144Sta Liatest D-DIDiagnostica Stago201401
+3K112818Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc.201211
+3K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20102—
+3K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101—
+3K091916Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20090—
+3K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+3K081732Innovance D-Dimer and Innovance D-Dimer ControlsSiemens Healthcare Diagnostics20080—
+3K070927Hemosil D-Dimer HSInstrumentation Laboratory CO20078—
+3K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.200711
+3K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated20040—
+3K042890Triage D-Dimer Test, Model 98100Biosite Incorporated20040Class I
+4K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH20260—
+4K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+4K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO20170—
+4K170314ACL AcuStarInstrumentation Laboratory CO20170—
+4K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504
+4K151534HemosIL D-Dimer HSInstrumentation Laboratory CO20151—
+4K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories20130—
+4K110303Stratus CS Acute Care D-DimerSiemens Healthcare Diagnostics201101
+4K073042Hemosil D-DimerInstrumentation Laboratory20080—
+5K160885HemosIL D-Dimer HSInstrumentation Laboratory CO20160—