510(k) Report

Devices descending from K082562

6 later devices reach Applied Biosystems 7500 Fast DX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141220Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareThermo Fisher Scientific (Life Technologies Holdin20143—
+1K093383Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq…bioMerieux, Inc.201011
+2K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc.201921
+2K102740Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)…bioMerieux, Inc.20110—
+3K252243Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co;20260—
+3K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.20230—