510(k) Report

Devices descending from DEN040011

10 later devices reach Amplichip CYP450 Test, Model 04381866190 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093420Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)Luminex Molecular Diagnostics, Inc.201001
+1K043576Roche Amplichip CYP450 TestRoche Molecular Systems, Inc.200581
+2K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated20103—
+2K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated20084—
+2K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc.20052—
+3K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.20131—
+3K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc.201201
+3K070804Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc.200711
+4K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.20230—
+4K073071EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation20090—