510(k) Report

Devices descending from K043576

8 later devices reach Roche Amplichip CYP450 Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated20103—
+1K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated20084—
+1K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc.20052—
+2K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.20131—
+2K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc.201201
+2K070804Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestNanosphere, Inc.200711
+3K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.20230—
+3K073071EQ-PRC LC Warfarin Genotyping KitTrimgen Corporation20090—