510(k) Report

Devices descending from K060564

8 later devices reach Infiniti System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132978Impact DX Factor V Leiden and Factor II Genotyping TestSequenom, Inc.20140—
+1K093129Illumina Verncode Genotyping Test for Facor V and Factor IIIllumina, Inc.20100—
+1K093128Illumina Beadxpress SystemIllumina, Inc.20100—
+1K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated20084—
+2K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated20103—
+3K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.20131—
+3K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc.201201
+4K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.20230—