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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 Reagents And Accessories.
510(k) Number K201814
Device Name 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 Kit
Applicant
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact Niya Su
Correspondent
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact Niya Su
Regulation Number864.5220
Classification Product Code
OYE  
Date Received07/01/2020
Decision Date 09/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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