510(k) Report

Devices descending from K020810

21 later devices reach Vidas D-Dimer New (DD2) Assay Model#30 442 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040882Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc.200419—
+1K030328Vidas D-Dimer New (DD2) Assay, Model 30 442bioMerieux, Inc.20030—
+2K162227STA® - Liatest® D-DiDiagnostica Stago201602
+2K141144Sta Liatest D-DIDiagnostica Stago201401
+2K112818Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc.201211
+2K093626Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20102—
+2K090264Hemosil D-Dimer HS 500, ControlsInstrumentation Laboratory CO20101—
+2K091916Innovance D-Dimer, Model OPBP09Siemens Healthcare Diagnostics20090—
+2K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+2K070927Hemosil D-Dimer HSInstrumentation Laboratory CO20078—
+2K062203Tina-Quant D-Dimer Test SystemRoche Diagnostics Corp.200711
+3K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH20260—
+3K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+3K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO20170—
+3K170314ACL AcuStarInstrumentation Laboratory CO20170—
+3K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504
+3K151534HemosIL D-Dimer HSInstrumentation Laboratory CO20151—
+3K112120Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetDiazyme Laboratories20130—
+3K110303Stratus CS Acute Care D-DimerSiemens Healthcare Diagnostics201101
+3K073042Hemosil D-DimerInstrumentation Laboratory20080—
+4K160885HemosIL D-Dimer HSInstrumentation Laboratory CO20160—