FDA 510(k) Applications Submitted by BD Biosciences

FDA 510(k) Number Submission Date Device Name Applicant
K060375 02/13/2006 BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 BD Biosciences
K062087 07/24/2006 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 BD Biosciences
K000897 03/21/2000 CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE BD Biosciences
K000611 02/23/2000 STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER BD Biosciences
K090967 04/06/2009 BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 BD Biosciences
K041074 04/26/2004 BD FACSCANTO WITH BD FACSANTO SOFTWARE BD Biosciences
K071141 04/24/2007 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 BD Biosciences
K071143 04/24/2007 BD TRITEST CD3/CD4/CD45, MODEL 340383 BD Biosciences
K081213 04/30/2008 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 BD Biosciences
K141468 06/03/2014 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) BD Biosciences


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