510(k) Report

Devices descending from P970007

9 later devices reach Imx Tacrolimus II Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc.200741
+1K060502Dimension Tacr Flex Reagent Cartridge, Model DF107Dade Behring, Inc.200603
+1K060503Dimension Tacr Calibrator, Model DC107Dade Behring, Inc.20061—
+1K060385Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentDade Behring, Inc.200601
+1K060371The Emit 2000 Tacrolimus CalibratorsDade Behring, Inc.20060—
+2K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.20230—
+2K173857Elecsys TacrolimusRoche Diagnostics20180—
+2K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics201502
+2K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp.201302