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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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