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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name counter, differential cell
510(k) Number BK030027
Tradename BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit
Device Name Counter, Differential Cell
Original Applicant
BD Biosciences
2350 qume drive
san jose,  CA  95131 1807
Regulation Number864.5220
Classification Product Code
Date Received05/05/2003
Decision Date 07/10/2003
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