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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 BK150307
Tradename BD FACSVia System with the BD Leucocount reagent Assay
Device Name Flow Cytometric Reagents and Accessories
Original Applicant
BD Biosciences
2350 qume drive
san jose,  CA  95131 1807
Regulation Number864.5220
Classification Product Code
OYE  
Date Received08/24/2015
Decision Date 09/16/2016
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 No
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