BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)— 510(k) K141468

Clearance details

Applicant

Bd Biosciences

Product code

Code OYE

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2014-06-03

Decision date

2015-02-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

• K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels2023-11-22
• K201814 — 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, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit2020-09-28
• K170974 — 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 TBNK2017-07-03
• K162897 — Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser2017-06-23
• K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS2015-04-10

• K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 6446112009-07-31
• K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 3390102008-08-14
• K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 3404022007-06-06
• K071143 — BD TRITEST CD3/CD4/CD45, MODEL 3403832007-06-06
• K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 3389622006-09-14

Malfunction

828

Total

828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →