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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 BK230835
Tradenames BD FACSLyric™ Flow Cytometer (662875, 662876, 662877, 662878, 663518), BD FACSuite™ Clinical BD Leucocount™ Assay Module (665732), BD Leucocount™ Kit (662415)
Device Name Flow Cytometric Reagents and Accessories
Original Applicant
Becton, Dickinson & Company
2350 qume dr
san jose,  CA  95131
Regulation Number864.5220
Classification Product Code
OYE  
Date Received04/25/2023
Decision Date 07/24/2023
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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