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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flow Cytometric Test System For Hematopoietic Neoplasms
510(k) Number K260215
Device Name 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
155 N. Mccarthy Blvd.
Milpitas,  CA  95035
Applicant Contact Jeff Yarch
Correspondent
Bd Biosciences
155 N. Mccarthy Blvd.
Milpitas,  CA  95035
Correspondent Contact Jeff Yarch
Regulation Number864.7010
Classification Product Code
PWD  
Subsequent Product Code
OYE  
Date Received01/23/2026
Decision Date 10/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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