FDA 510(k) Applications for Medical Device Product Code: CJW (Bromcresol Purple Dye-Binding, Albumin)

FDA 510(k) Applications for Medical Device Product Code "CJW"
(Bromcresol Purple Dye-Binding, Albumin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K990978	A.P. TOTAL CARE, INC.	ALBUMIN BCG, MODEL AL 103-01	05/25/1999
K203530	Abbott Ireland Diagnostics Division	Albumin BCP2	03/18/2022
K981814	ABBOTT LABORATORIES	ALBP	07/22/1998
K981457	ABBOTT MFG., INC.	ALBP	05/27/1998
K021636	INTERSECT SYSTEMS, INC.	ALBUMIN REAGENT	07/17/2002
K000483	RANDOX LABORATORIES, LTD.	RANDOX ALBUMIN	03/31/2000
K193001	Sentinel CH. SpA	Albumin BCP	12/19/2019
K132664	SIEMENS HEALTHCARE DIAGNOSTICS, INC.	ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR	10/16/2013