510(k) Report

Devices descending from K101683

3 later devices reach Infiniti CYP2C19 Assay through their predicates, nearest generation first.

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