510(k) Report

Devices descending from K070820

4 later devices reach Architect Tacrolimus: Model 1L77 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.20230—
+1K173857Elecsys TacrolimusRoche Diagnostics20180—
+1K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics201502
+1K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp.201302