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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 11 Results
ProductCode: GKZ Applicant: BD Biosciences Decision Date To: 09/30/2022
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counter, differential cell: BD Stem Cell Enumeration Kit BD Biosciences BK110037 10/19/2011
bd multitest 6-color tbnk reagent, model 644611 BD Biosciences K090967 07/31/2009
bd facscount cd4 reagents with model 339010 BD Biosciences K081213 08/14/2008
bd tritest cd3/cd4/cd45 with bd trucount absolute count tubes, model 340402 BD Biosciences K071141 06/06/2007
bd tritest cd3/cd4/cd45, model 340383 BD Biosciences K071143 06/06/2007
bd facscanto ii flow cytometer, model 338960; (5-3), model 339473; (4-2-2), model 338962 BD Biosciences K062087 09/14/2006
bd multitest 6-color tbnk reagent with bd trucount tubes with models 337 and 166 BD Biosciences K060375 06/06/2006
bd facscanto with bd facsanto software BD Biosciences K041074 09/17/2004
counter, differential cell: BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit BD Biosciences BK030027 07/10/2003
steller cd61 assay for use on the imagn 2000 microvolume fluorimeter BD Biosciences K000611 05/18/2000