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510(k) K232600

Device
DxFLEX Flow Cytometer; ClearLLab 10C Panels
Applicant
Beckman Coulter, Inc.
510(k) number
K232600
Product code
OYE
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-22
Date received
2023-08-28
Regulation
864.5220
Classification name
Flow Cytometric Reagents And Accessories.
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephanie Harlacz
Address
11800 SW 147 Ave. Miami FL US 33196 33196

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OYE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201814BD 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, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color KitBecton, Dickinson and Company2020-09-28
K170974BD 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 TBNKBecton, Dickinson and Company2017-07-03
K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 LaserBeckman Coulter2017-06-23
K141932AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOSBeckman Coulter, Inc.2015-04-10
K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)Bd Biosciences2015-02-27
K130373NAVIOS FLOW CYTOMETER SYSTEMBeckman Coulter, Inc.2013-09-18
K121445TETRACHROME REAGENTS AND TETRACXP SYSTEMBeckman Coulter, Inc.2013-07-26