510(k) Report

Devices descending from K073014

4 later devices reach Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated20103—
+2K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.20131—
+2K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc.201201
+3K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.20230—