510(k) Report

Devices descending from K181661

2 later devices reach QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252243Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co;20260—
+1K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.20230—