FDA 510(k) Applications for Medical Device Product Code: MLM (Enzyme Immunoassay, Tracrolimus)

FDA 510(k) Applications for Medical Device Product Code "MLM"
(Enzyme Immunoassay, Tracrolimus)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K060502	DADE BEHRING, INC.	DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107	05/18/2006
K060385	DADE BEHRING, INC.	EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT	04/06/2006
K070820	FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT TACROLIMUS: MODEL 1L77	08/01/2007
K050206	MICROGENICS CORP.	CEDIA TACROLIMUS ASSAY	03/15/2005
K123343	MICROGENICS CORP.	THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS	07/11/2013
K173857	Roche Diagnostics	Elecsys Tacrolimus	11/06/2018
K203833	Shanghai Genext Medical Technology Co., Ltd.	Tacrolimus Assay Kit	01/27/2023
K150168	SIEMENS HEALTHCARE DIAGNOSTICS	Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)	11/04/2015
K063868	WATERS CORPORATION	MASSTRAK IMMUNOSUPPRESSANTS KIT	05/25/2007