510(k) Report

Devices descending from K073720

6 later devices reach Esensor Warfarin Sensitivity and XT-8 Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183530TruDiagnosis SystemAkonni Biosystems, Inc.20190—
+1K113731Esensor Respiratory Viral PanelClinical Micro Sensors, Inc.20120—
+1K110786Esensor Warfarin Sensitivity Saliva TestGenMark Diagnostics, Inc.20111—
+1K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics20100—
+1K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics200912
+2K152612eSensor Warfarin Sensitivity Saliva TestGenmark Diagnostics, Incorporated20160—