FDA 510(k) Applications for Medical Device Product Code: OYE ()

FDA 510(k) Applications for Medical Device Product Code "OYE"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K141468	BD Biosciences	BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)	02/27/2015
K162897	BECKMAN COULTER	Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser	06/23/2017
K141932	BECKMAN COULTER, INC.	AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS	04/10/2015
K130373	BECKMAN COULTER, INC.	NAVIOS FLOW CYTOMETER SYSTEM	09/18/2013
K121445	BECKMAN COULTER, INC.	TETRACHROME REAGENTS AND TETRACXP SYSTEM	07/26/2013
K170974	Becton, Dickinson and Company	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK	07/03/2017
K201814	Becton, Dickinson and Company	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules,	09/28/2020