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)— 510(k) K260215

Name: FDA 510(k) clearance K260215
Creator: U.S. Food and Drug Administration
Published: 2026-10-20

Substantially Equivalent

Bd Biosciences

FDA 510(k) clearance K260215 for 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), Substantially Equivalent on 2026-10-20. Applicant: Bd Biosciences. Device class: 2.

Clearance details

Applicant: Bd Biosciences
Product code: Product code PWD
Device class: Class 2
Regulation: 21 CFR 864.7010
Advisory panel: Hematology
Date received: 2026-01-23
Decision date: 2026-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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