DxFLEX Flow Cytometer; ClearLLab 10C Panels— 510(k) K232600

Clearance details

Applicant

Beckman Coulter, Inc.

Product code

Code OYE

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2023-08-28

Decision date

2023-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miami, FL, US

• 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
• K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)2015-02-27

• K252169 — Access BNP II2026-03-24
• K254059 — Access anti-HBc IgM2026-03-13
• K253687 — Access anti-HBc Total2026-02-19
• K251995 — Access anti-HAV IgM2026-01-27
• K250588 — Access Rubella IgG2025-11-17

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 →

• Z-0541-2026 — DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.Class II·Ongoing·Beckman Coulter Inc.·20250922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232600.