510(k) K260215

Device: BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
Applicant: Bd Biosciences
510(k) number: K260215
Product code: PWD
Decision: Substantially Equivalent (SESE)
Decision date: 2026-10-20
Date received: 2026-01-23
Regulation: 864.7010
Classification name: Flow Cytometric Test System For Hematopoietic Neoplasms
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K183592	ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer	Beckman Coulter	2019-03-21
DEN160047	ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M	Beckman Coulter	2017-06-29