FDA 510(k) Applications for Medical Device Product Code: JFM (Enzymatic Method, Bilirubin)

FDA 510(k) Applications for Medical Device Product Code "JFM"
(Enzymatic Method, Bilirubin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K063845	BAYER HEALTHCARE, LLC	ADVIA CHEMISTRY TOTAL BILIRUBIN_2	12/07/2007
K053090	BECKMAN COULTER, INC.	DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR	12/16/2005
K152343	RANDOX LABORATORIES LIMITED	Direct Bilirubin	02/16/2016
K152344	RANDOX LABORATORIES LIMITED	Total Bilirubin	01/28/2016
K170065	Siemens Healthcare Diagnostics, Inc.	ADVIA« Chemistry Total Bilirubin_2 (TBIL_2)	03/09/2017
K050266	STANBIO LABORATORY	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	06/30/2005
K053132	WAKO CHEMICALS, USA, INC.	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	12/30/2005
K970985	WAKO CHEMICALS, USA, INC.	WAKO TOTAL BILIRUBIN V	04/21/1997
K053131	WAKO CHEMICALS, USA, INC.	WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191	12/30/2005